Walid M. Awni, Ph.D., ARF - Food and Drug Administration · PDF fileCurriculum Vitae-Awni 2...

Curriculum Vitae

Walid M. Awni, Ph.D., ARF Vice President, Clinical Pharmacology & Pharmacometrics

Research and Development Abbvie

Contact Information

Office D4PD, AP13A One North Waukegan Road, North Chicago, IL 60064 (847) 938-0547 (Office) [email protected] Employment History

Current Positions;

Mar 2013-Present: Vice President, Clinical Pharmacology & Pharmacometrics Research and Development, Abbvie Feb 1995-Present: Associate Research Fellow The Volwiler Society (Abbott’s/Abbvie’s Honorary Scientific Society) 1990 to Present: Adjunct Associate Professor Department of Pharmaceutics, College of Pharmacy University of Minnesota, Minneapolis, Minnesota 55455 Previous Positions within Abbott/Abbvie:

Apr 2005: Promoted to Senior Director, Clinical Pharmacology & Pharmacometrics

Oct 2001: Promoted to Global Director, Clinical Pharmacokinetics

May 2000: Promoted to Director, Clinical Pharmacokinetics

Sep 1997: Promoted to Manager, Clinical Pharmacokinetics & Toxicokinetics

Feb 1995: Promoted to Section Manager, Pharmacokinetics & Biopharmaceutics

Feb 1993: Promoted to Group Leader, Pharmacokinetics & Biopharmaceutics

Aug 1992: Senior Research Scientist, Pharmacokinetics & Biopharmaceutics

DESCRIPTIONS OF THE CLINICAL PHARMACOLOGY AND PHARMACOMETRICS (CPPM) DEAPRTMENTS AT ABBVIE The Clinical Pharmacology and Pharmacometrics organization at AbbVie leads the development of strategy, generation, analysis, interpretation, reporting, and the preparation of documents and communications with global regulatory agencies in the areas of clinical pharmacology,

Curriculum Vitae-Awni 2

pharmacokinetics, pharmacodynamics, pharmacometrics, biopharmaceutics, and pharmacogenetics. The Clinical Pharmacology and Pharmacometrics organization at AbbVie includes the following departments: 1) The Department of Clinical Pharmacokinetics and Pharmacodynamics; 2) The AbbVie Clinical Pharmacology Research Unit; 3) The Clinical Pharmacology Medical Department; 4) Department of Pharmacogenetics; 5) The Department of Pharmacometrics; and 6) The Department of Biometrics (PK/PD for Statistics). Abbvie Leadership Committees Memberships

Pipeline Leadership Forum Safety Review Board Development Review Committee Drug Safety Evaluation Committee Translational Sciences Team (Chair) Proof of Concept Team (Executive Champion) Trade and Professional Societies Activities

Industry Representative for the Advisory Committee for Pharmaceutical Science & Clinical Pharmacology (ACPS-CP) of the Food and Drug Administration, Center for Drug Evaluation and Research (Appointment effective November 1, 2015 through October 31, 2019. PhRMA Clinical-Preclinical Leadership Committee (Representing Abbvie) American Association of Pharmaceutical Scientists American Society for Clinical Pharmacology and Therapeutics American College of Clinical Pharmacology, Fellow Rho Chi Pharmacy Honor Society

Previous Positions before Joining Abbott/Abbvie:

1986 to 1992: Director, Pharmacokinetics & Drug Metabolism The Drug Evaluation Unit Hennepin County Medical Center Minneapolis, Minnesota 55415 1990 to 1992 Associate Professor Department of Pharmaceutics, College of Pharmacy University of Minnesota Minneapolis, Minnesota 55455 1984 to 1990 Assistant Professor Department of Pharmaceutics, College of Pharmacy University of Minnesota Minneapolis, Minnesota 55455


Teaching Experience

1982 to 1992 College of Pharmacy, University of Minnesota Undergraduate Courses Course Director: Principles of Drug Delivery Laboratory-1984 Co-Instructor: Principles of Drug Delivery-1984 Course Director: Introduction to Dosage Form Design-1984 &1985 Co-Instructor: Dispensing Pharmacy Laboratory-1985 Co-Instructor: Pathophysiology & Therapeutics-1988 to 1992 Graduate Courses Co-Instructor: Clinical Pharmacokinetics-1986 to 1992 Co-Instructor: Pharmacokinetics- 1984 to 1992 Instructor: Drug Transport-1985 Co-Instructor: Advanced Topics in Pharmacokinetics-1987 to 1992 Academic Qualifications Ph.D. in Pharmaceutics (Pharmacokinetics), College of Pharmacy, University of Minnesota, Minneapolis, Minnesota, USA B.S. in Pharmacy College of Pharmacy, University of Baghdad, Baghdad, Iraq Publications: Full Manuscripts (Published)

1. Polepally AR, Mensing S, Khatri A, Beck D, Liu W, Awni WM, Menon RM, Dutta S. Dose- and Formulation-Dependent Non-Linear Pharmacokinetic Model of Paritaprevir, a Protease Inhibitor for the Treatment of Hepatitis C Virus Infection: Combined Analysis from 12 Phase I Studies. Clin Pharmacokinet 2016 Mar 21. [Epub ahead of print]

2. Khatri A, Dutta S, Dunbar M, Podsadecki T, Trinh R, Awni W, Menon R. Evaluation of Drug-Drug Interactions Between Direct-Acting Anti-Hepatitis C Virus Combination Regimens and the HIV-1 Antiretroviral Agents Raltegravir, Tenofovir, Emtricitabine, Efavirenz, and Rilpivirine. Antimicrob Agents Chemother 2016 Mar 7. [Epub ahead of print]

3. Khatri A, Dutta S, Wang H, Podsadecki T, Trinh R, Awni W, Menon R. Evaluation of Drug-Drug Interactions Between Hepatitis C Antiviral Agents Ombitasvir, Paritaprevir/Ritonavir, and Dasabuvir and HIV-1 Protease Inhibitors. Clin Infect Dis 2016 Apr 15;62(8):972-9. Epub 2016 Jan 5.

4. Menon RM, Klein CE, Podsadecki TJ, Chiu YL, Dutta S, Awni WM, Pharmacokinetics and tolerability of paritaprevir, a direct-acting antiviral agent for HCV treatment, with and without ritonavir in healthy volunteers.. Br J Clin Pharmacol. 2015 Dec 28. doi: 10.1111/bcp.12873. [Epub ahead of print]

5. Mensing S, Polepally AR, König D, Khatri A, Liu W, Podsadecki TJ, Awni WM, Menon RM, Dutta S. Population Pharmacokinetics of Paritaprevir, Ombitasvir, Dasabuvir, Ritonavir, and Ribavirin in Patients with Hepatitis C Virus Genotype 1 Infection:


Combined Analysis from 9 Phase 1b/2 Studies. AAPS J 2016 Jan;18(1):270-80. Epub 2015 Nov 23.

6. King JR, Dutta S, Cohen D, Podsadecki TJ, Ding B, Awni WM, Menon RM. Drug-Drug Interactions between Sofosbuvir and Ombitasvir-Paritaprevir-Ritonavir with or without Dasabuvir. Antimicrob Agents Chemother 2015 Nov 23;60(2):855-61.

7. Badri PS, Dutta S, Wang H, Podsadecki TJ, Polepally AR, Khatri A, Zha J, Chiu YL, Awni WM, Menon RM. Drug Interactions with the Direct-Acting Antiviral Combination of Ombitasvir and Paritaprevir-Ritonavir. Antimicrob Agents Chemother 2015 Oct 12;60(1):105-14.

8. Khatri A, Menon RM, Marbury TC, Lawitz EJ, Podsadecki TJ, Mullally VM, Ding B, Awni WM, Bernstein BM, Dutta S. Pharmacokinetics and safety of co-administered paritaprevir plus ritonavir, ombitasvir, and dasabuvir in hepatic impairment. J Hepatol 2015 Oct;63(4):805-12. Epub 2015 Jun 10.

9. Badri P, Dutta S, Coakley E, Cohen D, Ding B, Podsadecki T, Bernstein B, Awni W, Menon R. Pharmacokinetics and Dose Recommendations for Cyclosporine and Tacrolimus When Coadministered With ABT-450, Ombitasvir, and Dasabuvir. Am J Transplant. 2015 May;15(5):1313-22.

10. Sharma S, Eckert D, Hyams JS, Mensing S, Thakkar RB, Robinson AM, Rosh JR, Ruemmele FM, Awni WM. Pharmacokinetics and exposure-efficacy relationship of adalimumab in pediatric patients with moderate to severe Crohn's disease: results from a randomized, multicenter, phase-3 study. Inflamm Bowel Dis 2015 Apr;21(4):783-92.

11. Menon RM, Badri PS, Wang T, Polepally AR, Zha J, Khatri A, Wang H, Hu B, Coakley EP, Podsadecki TJ, Awni WM, Dutta S. Drug-drug interaction profile of the all-oral anti-hepatitis C virus regimen of paritaprevir/ritonavir, ombitasvir, and dasabuvir. J Hepatol 2015 Jul;63(1):20-9. Epub 2015 Jan 31.

12. An G, Liu W, Duan WR, Nothaft W, Awni W, Dutta S. Population pharmacokinetics and exposure-uric acid analyses after single and multiple doses of ABT-639, a calcium channel blocker, in healthy volunteers. AAPS J 2015 Mar;17(2):416-26. Epub 2015 Jan 8. Erratum in: AAPS J 2015 Mar;17(2):481-92. 13.

13. Liu W, Dutta S, Kearns G, Awni W, Neville KA. Pharmacokinetics of hydrocodone/acetaminophen combination product in children ages 6-17 with moderate to moderately severe postoperative pain. J Clin Pharmacol 2015 Feb;55(2):204-11. Epub 2014 Sep 26.

14. Kaefer A, Yang J, Noertersheuser P, Mensing S, Humerickhouse R, Awni W, Xiong H. Mechanism-based pharmacokinetic/pharmacodynamic meta-analysis of navitoclax (ABT-263) induced thrombocytopenia. Cancer Chemother Pharmacol 2014 Sep;74(3):593-602. Epub 2014 Jul 23.

15. An G, Liu W, Katz DA, Marek GJ, Awni W, Dutta S. Population pharmacokinetics of the 11β-hydroxysteroid dehydrogenase type 1 inhibitor ABT-384 in healthy volunteers following single and multiple dose regimens. Biopharm Drug Dispos 2014 Oct;35(7):417-29. Epub 2014 Aug 30.

16. Xiong H, Pradhan RS, Nada A, Krivoshik AP, Holen KD, Rhodes JW, Gordon GB, Humerickhouse R, Awni WM. Studying navitoclax, a targeted anticancer drug, in


healthy volunteers--ethical considerations and risk/benefit assessments and management. Anticancer Res 2014 Jul;34(7):3739-46.

17. Chiu YL, Lorusso P, Hosmane B, Ricker JL, Awni W, Carlson DM. Results of a phase I, open-label, randomized, crossover study evaluating the effects of linifanib on QTc intervals in patients with solid tumors. Cancer Chemother Pharmacol 2014 Jan;73(1):213-7. Epub 2013 Nov 16.

18. An G, Liu W, Katz DA, Marek G, Awni W, Dutta S. Effect of ketoconazole on the pharmacokinetics of the 11β-hydroxysteroid dehydrogenase type 1 inhibitor ABT-384 and its two active metabolites in healthy volunteers: population analysis of data from a drug-drug interaction study. Drug Metab Dispos 2013 May;41(5):1035-45. Epub 2013 Feb 19.

19. Othman AA, Nothaft W, Awni WM, Dutta S. Effects of the TRPV1 antagonist ABT-102 on body temperature in healthy volunteers: pharmacokinetic/ pharmacodynamic analysis of three phase 1 trials. Br J Clin Pharmacol 2013 Apr;75(4):1029-40.

20. Dutta S, Awni W: Population pharmacokinetics of ABT-594 in subjects with diabetic peripheral neuropathic pain. J Clin Pharm Ther 2012 Aug;37(4):475-80. Epub 2011 Dec 7.

21. Dutta S, Hosmane BS, Awni W: Population analyses of efficacy and safety of ABT-594 in subjects with diabetic peripheral neuropathic pain. AAPS J. 2012 Jun; 14(2): 168–175. Epub 2012 Feb 11.

22. Othman AA, Lenz RA, Zhang J, Li J, Awni WM, Dutta S. Single- and multiple-dose pharmacokinetics, safety and tolerability of the selective alpha-7 neuronal nicotinic receptor agonist, ABT-107, in healthy human volunteers. J Clin Pharmacol 2011;51(4):512-526.

23. Noertersheuser P, Pradhan R, Klein C, Williams L, Palaparthy R, Garimella T, Lichtenberger O, Awni W. Exposure-Clinical Response Analysis of Paricalcitol in Patients with Chronic Kidney Disease (Stage 5) on Hemodialysis or Peritoneal Dialysis. J Clin Pharmacol. August 2012; 52 (8), 1162-1173.

24. Ng J, Chiu YL, Awni W, Bernstein B, Causemaker SJ, Klein CE. Pharmacokinetics and Safety of the Lopinavir/Ritonavir Tablet 500/125 mg Twice Daily Coadministered With Efavirenz in Healthy Adult Participants. J Clin Pharmacol August 2012; 52 (8),1248-54.

25. Othman AA, Nothaft W, Awni WM, Dutta S. Pharmacokinetics of the TRPV1 antagonist ABT-102 in healthy human volunteers: population analysis of data from three Phase 1 trials. J Clin Pharmacol 2012 Jul; 52(7):1028-41

26. Zhu T, Awni W, Hosmane B, Kelly M, Sleep D, Stolzenback J, Wan K, Chira T, Pradhan R. ABT-335, the choline salt of fenofibric acid, does not have a clinically significant pharmacokinetic interaction with rosuvastatin in humans. J Clin Pharmacol 2009; 49: (1):63-71.

27. Klein CE, Chiu YL, Awni W, Zhu T, Heuser RS, Doan T, Breitenbach J, Morris JB, Brun SC, Hanna GJ. The tablet formulation of lopinavir/ritonavir provides similar bioavailability to the soft gelatin capsule formulation with less pharmacokinetic variability and diminished food effect. J Acq Immun Def Synd 2007;44(4):401-411.


28. Chiu YL, Klein CE, Woodward WC, King KR, Naylor C, Awni W, Brun S. Lack of effect of gastric acid-reducing agents on the pharmacokinetics of lopinavir/ritonavir in HIV-infected patients. AIDS Patient Care and STDs 2007;21(4):247-251.

29. Palaparthy R, Pradhan R, Chan J, Rieser M, Chira T, Galitz L, Awni W, Williams LA. Effect of omeprazole on the pharmacokinetics of paricalcitol in healthy subjects. Biopharm Drug Dispos 2007;28(2):65-71.

30. Karyekar CS, Pradhan RS, Freeney T, Ji Q, Edeki T, Chiu W, Awni WM, Locke C, Schwartz LB, Granneman RG, O'Dea R. A phase I multiple-dose escalation study characterizing pharmacokinetics and safety of ABT-578 in healthy subjects. J Clin Pharmacol 2005;45(8):910-918.

31. Blakesley V, Awni W, Locke C, Ludden T, Granneman R, Braverman L. Are bioequivalence studies of levothyroxine sodium formulations in euthyroid volunteers reliable? Thyroid 2004;14 (3):191-200.

32. Roza A, Tomlanovich S, Merion R, Pollak R, Wright F, Rajagopalan P, Pruett T, Scandling J, Ryan J, Awni W, Schweitzer S, Greco R, Lam W, Nabulsi A, Hoffman R. Conversation of stable renal allograft recipients to a bioequivalent cyclosporine formulation. Transplantation 2002;74(7):1013-1017.

33. Dube LM, Swanson LJ, Awni WM. Zileuton, a leukotriene synthesis inhibitor in the management of chronic asthma-clinical pharmacokinetics and safety. Clin Rev Allerg Immu 1999;17:213-221.

34. Wong SL, Drajesk J, Chang MS, Witt G, Awni WM. Dose-proportional pharmacokinetics of a new 5-lipoxygenase inhibitor, ABT-761, in healthy volunteers. Biopharm Drug Dispos 1998;19:159-162.

35. Wong SL, Cavanaugh JH, Qian J, Hansen R, Awni WM. Lack of CYP 1A2 interaction effect of ABT-761 on the pharmacokinetics of theophylline. Am J Ther 1998;5:303-306.

36. Wong SL, Drajesk J, Chang MS, Lanni C, Witt G, Hansen H, Awni WM. Pharmacokinetics and pharmacodynamics of single and multiple oral doses of a novel 5-lipoxygenase inhibitor (ABT-761) in healthy volunteers. Clin Pharmacol Ther 1998;63:324-331.

37. Wong SL, O'Dea R, Dube L, Awni WM. Effects of ABT-761, a novel 5-lipoxygenase inhibitor, on the pharmacokinetics of a single dose of ethinyl estradiol and levonorgestrel in healthy female volunteers. J Clin Pharmacol 1998;38:642-648.

38. Wong SL, Kearns GL, Kemp JP, Drajesk J, Chang M, Locke CS, Dube LM, Awni WM. Pharmacokinetics of a novel 5-lipoxygenase inhibitor (ABT-761) in pediatric patients with asthma. Eur J Clin Pharmacol 1998;54:715-719.

39. Awni WM, Cavanaugh JH, Leese P, Kasier JF, Cao G, Locke CS, Dube LM. The pharmacokinetic and pharmacodynamic interaction between zileuton and terfenadine. Eur J Clin Pharmacol 1997;52:49-54.

40. Awni WM, Locke CS, Dube LM, Cavanaugh JH. Evaluation of the diurnal variation in the pharmacokinetics of zileuton in healthy volunteers. J Clin Pharmacol 1997;37:388-394.


41. Awni WM, Wong W, Chu S-Y, Patterson K, Hansen R, Machinist JM, Drajesk J, Keane WF, Halstenson CE. Pharmacokinetics of zileuton and its metabolites in subjects with renal impairment. J Clin Pharmacol 1997;37:395-404.

42. Sramek JJ, Mack RJ, Awni WM, Hourani J, Jhee SS, Barto S, Cutler NR. Two rapid dose titrations of sertindole in patients with schizophrenia. J Clin Psychopharmacol 1997;17:419-422.

43. Wong SL, Cavanaugh JH, Shi H, Awni WM, Granneman GR. Effect of divalproex sodium on amitriptyline and nortriptyline pharmacokinetics. Clin Pharmacol Ther 1996;60:48-53.

44. Awni WM, Granneman GR, Locke C, Brandwein SR, Dube LM. Population pharmacokinetics of zileuton, a selective 5-lipoxygenase inhibitor, in patients with rheumatoid arthritis. Eur J Clin Pharmacol 1995;48:155-160.

45. St. Peter JV, Braeckman RA, Granneman GR, Locke CS, Cavanaugh JH, Awni WM. The effect of zileuton on antipyrine and indocyanine green disposition. Clin Pharmacol Ther 1995;57:299-308.

46. Fischer AR, McFadden CA, Frantz R, Awni WM, Cohn J, Drazen JM, Israel E. Effect of chronic 5-lipoxygenase inhibition on airway hyperresponsiveness in asthmatic subjects. Am J Resp Crit Care Med 1995;152:1203-1207.

47. Awni WM, Halstenson CE, Nayak RK, Opsahl JA, Desiraju RK, Minn FL, Matzke GR. Pharmacokinetics of bepridil and two of its metabolites in patients with end-stage renal disease. J Clin Pharmacol 1995;35:379-383.

48. St. Peter JV, Awni WM, Granneman GR, Karol MD. The effects of lansoprazole on the disposition of antipyrine and indocyanine green in normal human subjects. Am J Ther 1995;2:561-568.

49. Wong SL, Awni WM, Cavanaugh JH, El-Shourbagy T, Locke C, Dube LM. The pharmacokinetics of single oral doses of zileuton 200 to 800 mg, its enantiomers, and its metabolites, in normal healthy volunteers. Clin Pharmacokin 1995;2(Suppl. 2):9-21.

50. Awni WM, Braeckman RA, Granneman GR, Witt G, Dube LM. Pharmacokinetics and pharmacodynamics of zileuton after oral administration of single and multiple dose regimens of zileuton 600 mg in healthy volunteers. Clin Pharmacokin 1995;29(Suppl. 2):22-33.

51. Braeckman RA, Granneman GR, Locke CS, Machinist JM, Cavanaugh JH, Awni WM. The pharmacokinetics of zileuton in healthy young and elderly volunteers. Clin Pharmacokin 1995;29(Suppl. 2):42-48.

52. Awni WM, Cavanaugh JH, Braeckman RA, Chu S-YM, Patterson KJ, Machinist JM, Granneman GR. The effect of mild or moderate hepatic impairment (cirrhosis) on the pharmacokinetics of zileuton. Clin Pharmacokin 1995;29(Suppl. 2):49-61.

53. Awni WM, Cavanaugh JH, Witt G, Granneman GR, Dube LM. The effect of food on the pharmacokinetics of zileuton. Clin Pharmacokin 1995;29(Suppl. 2):62-66.

54. Awni WM, Hussein Z, Granneman GR, Patterson KJ, Dube LM, Cavanaugh JH. Pharmacodynamic and stereoselective pharmacokinetic interactions between zileuton and warfarin in humans. Clin Pharmacokin 1995;29(Suppl. 2):67-76.


55. Granneman GR, Braeckman RA, Locke CS, Cavanaugh JH, Dube LM, Awni WM. Effect of zileuton on theophylline pharmacokinetics. Clin Pharmacokin 1995;29(Suppl. 2):77-83.

56. Awni WM, Hussein Z, Cavanaugh JH, Granneman GR, Dube LM. Assessment of the pharmacokinetic interaction between zileuton and digoxin in humans. Clin Pharmacokin 1995;29(Suppl. 2):92-97.

57. Awni WM, Braeckman RA, Locke CS, Dube LM, Granneman GR. The influence of multiple oral doses of zileuton on the steady state pharmacokinetics of sulfasalazine and its metabolites, sulfapyridine and N-acetylsulfapyridine. Clin Pharmacokin 1995;29(Suppl. 2):98-104.

58. Awni WM, Cavanaugh JH, Tzeng T-B, Witt G, Granneman GR, Dube LM. Pharmacokinetic interactions between zileuton and prednisone. Clin Pharmacokin 1995;29(Suppl. 2):105-111.

59. Awni WM, Braeckman RA, Cavanaugh JH, Locke CS, Linnen PJ, Granneman GR, Dube LM. The pharmacokinetic and pharmacodynamic interactions between the 5-lipoxygenase inhibitor zileuton and the cyclo-oxygenase inhibitor naproxen in human volunteers. Clin Pharmacokin 1995;29(Suppl. 2):112-124.

60. Hirata-Dulas CAI, Awni WM, Matzke GR, Halstenson CE, Guay DRP. Evaluation of two intravenous single bolus methods for measuring effective renal plasma flow. Am J Kidney Dis 1994;23:374-381.

61. Carter GW, Bell RL, Marsh K, Lanni C, Awni WM, Bouska J, Stewart A, Hansen R, Dube LM, Brooks DW. Stereoselective metabolism of the 5-lipoxygenase inhibitor A-78773. Ann NY Acad Sci 1994;744:262-273.

62. Awni WM, Hoff JV, Shapiro BE, Halstenson CE. A dose ranging pharmacokinetic study of sodium diethyldithiocarbamate in normal healthy volunteers. J Clin Pharmacol 1994;34:1183-1190.

63. Railker AM, Awni WM, Camp RJ, Rahman YE. Studies of an oral iron chelator: 1,2 dimethyl 3-hydroxy-pyrid-4-one: Mechanism of intestinal absorption. J Pharm Pharmacol 1993;45:400-405.

64. Luke DR, Awni WM, Halstenson CE, Opsahl JA, Matzke GR. Bioavailability of labetalol in patients with end-stage renal disease. Ther Drug Monit 1992; 14:203-208.

65. Awni WM. Pharmacodynamics monitoring of cyclosporine. Clin Pharmacokin 1992; 23:428-448.

66. Halstenson CE, Wong MO, Herman CS, Heim-Duthoy KL, Teal MA, Affrime MB, Kelloway JH, Keane WF, Awni WM. Effect of concomitant administration of piperacillin on the disposition of isepamicin and gentamicin in patients with end-stage renal disease. Antimicrob Agents Ch 1992;36:1832-1836.

67. St. Peter JV, Halstenson CE, Awni WM. Antipyrine plasma and urine metabolite disposition with lorazepam coadministration. Pharmacotherapy 1991;11(2):171-174.

68. Kasiske BL, Tortorice KL, Heim-Duthoy KL, Awni WM, Rao KV. The adverse impact of cyclosporine on serum lipids in renal transplant recipients. Am J Kidney Dis 1991;17:700-707.


69. St. Peter JV, Abul-Hajj Y, Awni WM. The pharmacokinetics of antipyrine and three of its metabolites in the rabbit: intravenous administration of pure metabolites. Pharm Res 1991;8:1470-1476.

70. Kelloway JS, Awni WM, Lin CC, Lin J, Affrime MB, Keane WF, Matzke GR, Halstenson CE. Pharmacokinetics of ceftibuten-cis and its trans metabolite in healthy volunteers and in patients with chronic renal insufficiency. Antimicrob Agents Chemother 1991;35:2267-2274.

71. Halstenson CE, Kelloway JS, Affrime MB, Lin CC, Teal MA, Shapiro BE, Awni WM. Isepamicin disposition in subjects with various degrees of renal function. Antimicrob Agents Chemother 1991;35:2382-2387.

72. Awni WM, St. Peter WL, Guay DRP, Kenny MT, Matzke GR. Teicoplanin measurement in patients with renal failure: comparison of fluorescence polarization immunoassay, microbiological assay, and high performance liquid chromatographic assay. Ther Drug Monit 1991;13:511-517.

73. Awni WM, Heim-Duthoy KL, Kasiske BL. Therapeutic monitoring of cyclosporine utilizing pharmacokinetics studies. Clin Chem 1991;37:1891-1892.

74. St. Peter JV, Awni WM. Quantifying hepatic function in the presence of liver disease with antipyrine and metabolites. Clin Pharmacokin 1991 20(1):50-65.

75. Kolars JC, Awni WM, Merion RM, Watkins PB. First-pass metabolism of cyclosporine A by the gut. Lancet 1991;338:1488-1490.

76. Venkataram S, Awni WM, Jordan KR, Rahman YE. Pharmacokinetics of two alternative dosage forms for cyclosporine: liposomes and intralipids. J Pharm Sci 1990;79:216-219.

77. Maloney JA, Awni WM. High performance liquid chromatographic analysis of isepamicin in plasma, urine and dialysate. J Chromatogr 1990;526:487-496.

78. Awni WM, Yeh J, Halstenson CE, Opsahl JA, Chung M, Matzke GR. Effect of hemodialysis on the pharmacokinetics of cetirizine. Eur J Clin Pharmacol 1990;38:67-69.

79. Awni WM, St. Peter JV, Kovarik JM, Matzke GR. Disposition of antipyrine and acetaminophen given alone and in combination to human subjects. Pharm Res 1990;7:204-207.

80. Heim-Duthoy KL, Peltier GL, Awni WM. Steady-state pharmacokinetics of fleroxacin in patients with skin and skin structure infections. Antimicrob Agents Chemother 1990;34(5):922-923.

81. Awni WM, Heim-Duthoy KL, Kasiske BL. Monitoring of cyclosporine by serial post-transplant pharmacokinetic studies in renal transplant patients. Transplant Proc 1990;22(3):1343-1344.

82. Awni WM, Heim-Duthoy KL, Kasiske BL. Impact of lipoproteins on cyclosporine pharmacokinetics and biological activity in transplant patients. Transplant Proc 1990;22(3):1193-1196.


83. Tortorice KL, Heim-Duthoy KL, Awni WM, Rao KV, Kasiske BL. The effect of calcium channel blockers on cyclosporine and metabolites in renal transplant recipients. Ther Drug Monit 1990;12:321-328.

84. Awni WM, Kasiske BL, Heim-Duthoy KL, Rao KV. Long-term cyclosporine pharmacokinetic changes in renal transplant recipients: effects of binding and metabolism. Clin Pharmacol Ther 1989;45:41-48.

85. Guay DRP, Awni WM, Halstenson CE, Kenny MT, Keane WF, Matzke GR. Teicoplanin pharmacokinetics in patients undergoing continuous ambulatory peritoneal dialysis after intravenous and intraperitoneal dosing. Antimicrob Agents Chemother 1989;33:2012-2015.

86. Awni WM, Bakker LJ. Antipyrine, indocyanine green and lorazepam determined in plasma by high-pressure liquid chromatography. Clin Chem 1989;35:2124-2126.

87. St. Peter JV, Awni WM. Modified high-performance liquid chromatographic assay for antipyrine and its three major metabolites in urine. J Chromatogr 1989;494:424-427.

88. Hirata CAI, Guay DRP, Awni WM, Stein DJ, Peterson PK. Steady state pharmacokinetics of intravenous and oral ciprofloxacin in elderly patients. Antimicrob Agents Chemother 1989;33:1927-1931.

89. Guay DRP, Awni WM, Findlay JW, Halstenson CE, Abraham PA, Opsahl JA, Jones EC, Matzke GR. Pharmacokinetics and pharmacodynamics of codeine in end-stage renal disease. Clin Pharmacol Ther 1988;43:63-71.

90. Awni WM, Skaar DJ, Schwenk MH, Sirgo MA, Plachetka JR, Matzke GR. Interindividual and intraindividual variability in labetalol pharmacokinetics. J Clin Pharmacol 1988;28:344-349.

91. Guay DRP, Awni WM, Halstenson CE, Findlay JW, Opsahl JA, Abraham PA, Jones EC, Matzke GR. Pharmacokinetics of codeine after single and multiple oral dose administration to normal volunteers. J Clin Pharmacol 1988;27:983-987.

92. Guay, DRP, Awni WM, Peterson PK, Obaid S, Stein D, Breitenbucher R, Matzke GR. Single and multiple dose pharmacokinetics of oral ciprofloxacin in elderly patients. Int J Clin Pharmacol Ther Toxicol 1988;26:279-284.

93. Awni WM, Maloney JA. Optimized high-performance liquid chromatographic method for the analysis of cyclosporine and three of its metabolites in blood and urine. J Chromatography 1988;425:233-236.

94. Awni WM, Kasiske BL, Heim-Duthoy KL, Rose M, Rao KV, Bloom P, Ney A, Andrisevic J, Odland M, Anderson RC. Changes in the pharmacokinetics of cyclosporine and three of its metabolites in renal transplant patients early in post-transplant period. Transplant Proc 1988;20(Suppl 2):623-624.

95. Kasiske BL, Awni WM, Heim-Duthoy KL, Rao KV, Ney A, Andrisevic J, Odland M, Rose M, Anderson RC. Alterations in cyclosporine pharmacokinetics after renal transplantation are linked to rapid increases in blood hematocrit. Transplant Proc 1988;20(Suppl 2):485-486.


96. Kasiske BL, Heim-Duthoy KL, Rao KV, Awni WM. The relationship between cyclosporine pharmacokinetic parameters and subsequent acute rejection in renal transplant recipients. Transplantation 1988;46:716-722.

97. Awni WM, Maloney JA, Heim-Duthoy KL. Liquid chromatographic determination of fleroxacin in serum and urine. Clin Chem 1988;34:2330-2332.

98. Matzke GR, Yeh J, Awni WM, Halstenson CE, Chung M. Pharmacokinetics of cetirizine in the elderly and patients with renal insufficiency. Ann Allergy 1987;59:25-30.

99. Luke DR, Kasiske BL, Matzke GR, Awni WM, Keane WF. Effects of cyclosporine on the isolated perfused rat kidney. Transplantation 1987;43:795-799.

100. Guay DRP, Peterson PK, Awni WM, Obaid S, Breitenbucher R, Matzke GR. Pharmacokinetics of ciprofloxacin in acutely ill and convalescent elderly patients. Am J Med 1987;82(Suppl 4A):124-129.

101. O'Connell ME, Awni WM, Goodman M, Cass O, Melikian AP, Wright GD, Matzke GR. Bioavailability and disposition of metoclopramide following acute and chronic administration to patients with diabetic gastroparesis. J Clin Pharmacol 1987;27:610-614.

102. Awni WM, Clarkson J, Guay DRP. Determination of ciprofloxacin and its 7-ethylenediamine metabolite (R3964) in human serum and urine by high-performance liquid chromatography. J Chromatography 1987;419:414-420.

103. Luke DR, Matzke GR, Clarkson JT, Awni WM. Improved liquid-chromatographic assay of labetalol in plasma. Clin Chem 1987;33:1450-1452.

104. Sawchuk RJ, Awni WM. Absorption of cyclosporine from rabbit small intestine in situ. J Pharm Sci 1986;75:1151-1156.

105. Awni WM, Sawchuk RJ. The pharmacokinetics of cyclosporine: I. single dose and constant-rate infusion studies in the rabbit. Drug Metab Dispos 1985;13:127-132.

106. Awni WM, Sawchuk RJ. The pharmacokinetics of cyclosporine: II. blood-plasma distribution and binding studies. Drug Metab Dispos 1985;13:133-138.

107. Awni WM. Cyclosporine: a literature review. Minnesota Pharmacist 1985;39:6-11.

Book Chapters

1. Dube LM, Swanson LJ, Awni WM, Ochs R, Bell R, Carter G. Zileuton, the first leukotriene synthesis inhibitor for use in the management of chronic asthma. in “Five-Lipoxygenase Products in Asthma” Drazen JM, Dahlén SE, and Lee TH (Editors), “Lung Biology in Health and Disease” series (Lenfant C, Executive Editor, Volume 120), Marcel Dekker, New York, 1998, 391-428.

Presentations (Posters/Podium Abstracts) in International Scientifics Meetings

1. Kosloski MP, Dutta S, Zhao W, Wu J, Pugatch D, Asatryan A, Kort J, Awni W, Liu W. Drug-drug interactions between next generation direct acting antivirals ABT-493 and ABT-530 with cyclosporine or tacrolimus in healthy subjects. The Liver Meeting - 66th


Annual Meeting of the American Association for the Study of Liver Diseases November 13-17, 2015, San Francisco, California

2. Mostafa NM, Robinson AM, Sharma S, Sandborn WJ, Ghosh S, Hanauer S, Colombel J-F, Thakkar R, Awni WM. Adalimumab serum concentration as a predictor for clinical efficacy in ulcerative colitis. 2015 Digestive Disease Week May 16 – 19, 2015, Washington, DC

3. A.R. Polepally, P. Badri, E.P. Coakley, A. Parikh, L. Rodrigues Jr, B.A. DaSilva-Tillmann, S. Mensing, T.J. Podsadecki, W.M. Awni, S. Dutta, R.M. Menon. Effect of comedications on paritaprevir, ritonavir, ombitasvir, dasabuvir and ribavirin pharmacokinetics. 16th International Workshop on Clinical Pharmacology of HIV and Hepatitis Therapy May 26-28, 2015: Washington, DC, USA, Reviews in Antiviral Infectious disease, 2015, 4:56.

4. P. Badri, S. Dutta, H. Wang, T. Podsadecki, A. Polepally, A. Khatri, J. Zha, Y. Chiu, W. Awni, R. Menon. Drug Interactions with the Direct-Acting Antiviral Combination of Ombitasvir and Paritaprevir/Ritonavir (2D Regimen). 16th International Workshop on Clinical Pharmacology of HIV and Hepatitis Therapy May 26-28, 2015: Washington, DC, USA, Reviews in Antiviral Infectious disease, 2015, 4:59.

2. A Khatri, S Mensing, T Podsadecki, W Awni, R Menon, S Dutta, Exposure-Response Analyses For Efficacy (SVR12) for the Direct Acting Antiviral Regimen of ABT-450/r, Ombitasvir with Dasabuvir ± Ribavirin In Subjects with HCV Genotype 1 Infection. International Liver Conference 2015, Vienna, Austria. Journal of Hepatology, 2015, Volume 62, Supplement 2, Pages S682.

3. S Mensing, S Sharma, D Eckert, A Polepally, A Khatri, T Podsadecki, W Awni, R Menon, S Dutta, Pharmacokinetics of paritaprevir, ombitasvir, dasabuvir, ritonavir and ribavirin in subjects with HCV genotype 1 infection in phase 3 studies. International Liver Conference 2015, Vienna, Austria. Journal of Hepatology, 2015, Volume 62, Supplement 2, Pages S644.

4. J King, S Dutta, D Cohen, T J. Podsadecki, B Ding, W Awni, and R Menon, No Significant Interaction among Ombitasvir/Paritaprevir/Ritonavir ± Dasabuvir and Sofosbuvir. International Liver Conference 2015, Vienna, Austria. Journal of Hepatology, 2015, Volume 62, Supplement 2, Pages S681.

5. Khatri, S. Dutta, U. Das, E. Coakley, T. Podsadecki, W. Awni, R. Menon, Drug-Drug interactions of pravastatin and rosuvastatin with the direct acting antiviral combination of ABT-450/r, ombitasvir and dasabuvir in healthy volunteers. [abstract PI-012], American Society for Clinical Pharmacology and Therapeutics, March 3-7, 2015: New Orleans, LA, USA. Clinical Pharmacology & Therapeutics, 97, Issue Supplement S1: S24. doi: 10.1002/cpt.52

6. T. Wang, S. Dutta, E. Coakley, U. Das, T. J. Podsadecki, W. Awni, R. Menon, Pharmacokinetics, safety and tolerability of the coadministration of ketoconazole with ABT-450/r, ombitasvir and dasabuvir in healthy adult subjects [abstract PI-014], American Society for Clinical Pharmacology and Therapeutics, March 3-7, 2015: New Orleans, LA, USA. Clinical Pharmacology & Therapeutics, 97, Issue Supplement S1: S25. doi: 10.1002/cpt.52


7. P. Badri, S. Dutta, L. Rodrigues, Jr, B. Ding, T. Podsadecki, W. Awni, R. Menon, Drug-Drug interactions of digoxin with the HCV direct acting antiviral (DAA) combination of ABT-450/r, ombitasvir and dasabuvir [abstract PI- 015], American Society for Clinical Pharmacology and Therapeutics, March 3-7, 2015: New Orleans, LA, USA. Clinical Pharmacology & Therapeutics, 97, Issue Supplement S1: S25. doi: 10.1002/cpt.52

8. P. Badri, S. Dutta, A. Asatryan, H. Wang, T. Podsadecki, W. Awni, R. Menon, Drug-Drug interactions of carbamazepine with the HCV direct acting antiviral (DAA) combination ofABT-450/r, ombitasvir and dasabuvir [abstract PI-011]. American Society for Clinical Pharmacology and Therapeutics, March 3-7, 2015: New Orleans, LA, USA. Clinical Pharmacology & Therapeutics, 97, Issue Supplement S1: S23. doi: 10.1002/cpt.52

9. C. Lin, R. Menon, W. Liu, S. Mensing, T. Podsadecki, N. Shulman, B. DaSilva-Tillmann, W. Awni, S. Dutta, Exposure-safety response relationship for ABT-450/ritonavir, ombitasvir, dasabuvir and ribavirin in hepatitis c genotype 1 virus-infected subjects in phase III studies [abstract PI-016]. American Society for Clinical Pharmacology and Therapeutics, March 3-7, 2015: New Orleans, LA, USA. Clinical Pharmacology & Therapeutics, 97, Issue Supplement S1: S25-23. doi: 10.1002/cpt.52

10. Polepally, S. Dutta, T. Baykal, B. Hu, T. Podsadecki, W. Awni, R. Menon. Drug-drug interactions of omeprazole with the HCV direct acting antiviral (DAA) combination of ABT-450/r, ombitasvir and dasabuvir [abstract PII 062]. American Society for Clinical Pharmacology and Therapeutics, March 3-7, 2015: New Orleans, LA, USA. Clinical Pharmacology & Therapeutics, 97: S60–S96. doi: 10.1002/cpt.52.

11. Amit Khatri, Sandeep Dutta, Thomas Marbury, Richard A Preston, Lino Rodrigues, Haoyu Wang, Walid Awni, Rajeev Menon. The Pharmacokinetics and Safety of the Direct Acting Antiviral Regimen of ABT-450/r, Ombitasvir with/without Dasabuvir in Subjects with Mild, Moderate and Severe Renal Impairment Compared to Subjects with Normal Renal Function. AASLD, The Liver Meeting 2014, Boston, MA. Hepatology, Volume 60, Issue Supplement S1, 2014.

12. Prajakta Badri, Apurvasena Parikh, Eoin Coakley, Bifeng Ding, Walid Awni, Sandeep Dutta, Rajeev Menon. Pharmacokinetics of Cyclosporine and Tacrolimus, Following Coadministration with the Direct Acting Antiviral Combination, ABT-450/r, Ombitasvir and Dasabuvir, in Liver Transplant Patients with Genotype-1 HCV Infection. AASLD, The Liver Meeting 2014, Boston, MA. Hepatology, Volume 60, Issue Supplement S1, 2014.

13. P. Badri, D. Cohen, B. Ding, T. Podsadecki, B. Bernstein, W. Awni, S. Dutta, R. Menon, Pharmacokinetics, Safety and Tolerability of Cyclosporine or Tacrolimus Following Co-administration of ABT-450/r, ABT-267 and ABT-333 in Healthy Subjects[abstract B1121], World Transplant Congress 2014, Am J Transplant 2014;14(S3):736.

14. Akshanth Polepally, Sven Mensing, Amit Khatri, Wei Liu, Walid Awni, Rajeev Menon, Sandeep Dutta. Dose- and formulation-dependent non-linear pharmacokinetic model of ABT-450, a protease inhibitor for the treatment of HCV: combined analyses from 12 phase 1 studies [Poster # M-065], American Conference on Pharmacometrics, 2014: Las Vegas, NV, USA, J Pharmacokinet Pharmacodyn (2014) 41:S36


15. Sven Mensing, Akshanth Polepally, Denise Ko¨nig, Amit Khatri, Wei Liu, Thomas Podsadecki, Walid Awni, Rajeev Menon, Sandeep Dutta. Population pharmacokinetics of ABT-450, ombitasvir, dasabuvir, ritonavir and ribavirin in subjects with HCV genotype 1 infection [Poster # T-007], American Conference on Pharmacometrics, 2014: Las Vegas, NV, USA). J Pharmacokinet Pharmacodyn (2014) 41:S42-S43

16. Chih-Wei Lin, Rajeev Menon, Wei Liu, Sven Mensing, Thomas Podsadecki, Nancy Shulman, Barbara DaSilva-Tillmann, Walid Awni, Sandeep Dutta, Exposure-Safety Response Relationship for ABT 450/Ritonavir, Ombitasvir, Dasabuvir and Ribavirin in Hepatitis C Genotype 1 Virus-Infected Subjects – Analyses of Data from Phase 2 Studies [Poster # T-040], American Conference on Pharmacometrics, 2014, Las Vegas, NV, USA). J Pharmacokinet Pharmacodyn (2014) 41:S56-S57

17. R. Menon, P. Badri, U. Das, T. Wang, A. Polepally, A. Khatri, H. Wang, B. Hu, E. Coakley, T. Podsadecki, W. Awni, S. Dutta, Drug-Drug Interactions with Direct Acting Antiviral Combination Therapy of ABT-450/r, Ombitasvir and Dasabuvir, ICAAC, June 2014, Washington DC (encore at AASLD-EASL Special Conference on HCV 2014)

18. A. Khatri, T. Wang, H. Wang, T. Podsadecki, R. Trinh, W. Awni, S. Dutta, R. Menon, Drug-Drug Interactions of the Direct Acting Antiviral Regimen of ABT-450/r, Ombitasvir and Dasabuvir with Emtricitabine + Tenofovir, Raltegravir, Rilpivirine and Efavirenz, ICAAC, June 2014, Washington DC (encore at AASLD-EASL Special Conference on HCV 2014)

19. A. Khatri, T. Wang, H. Wang, T. Podsadecki, R. Trinh, W. Awni, S. Dutta, R. Menon, Drug-Drug Interactions of the Direct Acting Antiviral Regimen of ABT-450/r, Ombitasvir and Dasabuvir with HIV Protease Inhibitors, ICAAC, June 2014, Washington DC (encore at AASLD-EASL Special Conference on HCV 2014)

20. Liu W, Katz D, Tracy K, Locke C, Awni W, Dutta S. Pharmacokinetics and Safety Following Single Escalating Doses, Food Effect and Ketoconazole Interaction of Arginine Vasopressin Type-1B (V1B) Receptor Antagonist ABT-436 in Healthy Volunteers. 116th Annual Meeting American Society for Clinical Pharmacology and Therapeutics March 3-7, 2015, New Orleans Louisiana, USA

21. Liu W, Katz D, Tracy K, Locke C, Awni W, Dutta S. Pharmacokinetics and Safety of Arginine Vasopressin Type-1B (V1B) Receptor Antagonist ABT-436 in Healthy Volunteers Following Multiple Doses. 116th Annual Meeting American Society for Clinical Pharmacology and Therapeutics March 3-7, 2015, New Orleans Louisiana, USA

22. Singh I, Liu W, Katz D, Awni W, Dutta S. Population Pharmacokinetic Pharmacodynamic (PK/PD) Analyses of Arginine Vasopressin Type-1B (V1B) Receptor Antagonist Effect on Cortisol. 16th Annual Meeting American Society for Clinical Pharmacology and Therapeutics March 3-7, 2015, New Orleans Louisiana, USA

23. Mostafa NM, Robinson AM, Sharma S, Sandborn WJ, Ghosh S, Hanauer S, Colombel J-F, Thakkar R, Awni WM. Adalimumab Serum Concentration as a Predictor for Clinical Efficacy in Ulcerative Colitis. 22nd Annual Conference United European Gastroenterology Week October 18-22, 2014, Vienna, Austria

24. Sharma S, Noertersheuser P, Mostafa NM, Okun M, Awni WM. Pharmacokinetics of Adalimumab in Adult Patients with Moderate to Severe Chronic Plaque Psoriasis. 23rd


Congress European Academy of Dermatology and Venereology October 8–12, 2014, Amsterdam, Netherlands

25. Goss S, Wang S, Klein C, Medema J, Awni W. Safety, Tolerability and Pharmacokinetics of ABT-981, an IL-1a and IL-1ß Dual Target Biologic Drug in Development for Osteoarthritis, following Single Dose Administration in Healthy Subjects 2014 European League Against Rheumatism June 11-14, 2014, Paris France.

26. Ng J, Klein CE, Awni WA, Williams LA. Pharmacokinetics of Elagolix, an Oral Gonadotropin-Releasing Hormone (GNRH) Antagonist in Healthy Premenopausal Han Chinese and Japanese Female Subjects 12th World Congress on Endometriosis 2014 April 30th to May 3rd 2014, Sao Paulo, Brazil

27. Goss, S, Ahmed, G, Klein, C, Awni, W, Mozaffarian, N, Kaeley, G. Adalimumab in Combination with High and Low Dose-Methotrexate in Rheumatoid Arthritis Patients with Inadequate Response to Methotrexate: Pharmacokinetic Results from the MUSICA Study. 2013 Annual Scientific Meeting American College of Rheumatology/ARHP October 25–30, 2013, San Diego, United States

28. Goss, S, Klein, C, Awni, W, Kupper, H, Burmester, G. Adalimumab and Methotrexate Pharmacokinetics Following Combination Therapy With Different Methotrexate Doses in Methotrexate and Biologic-Naïve Rheumatoid Arthritis Patients: Concerto Study. 2013 Annual Scientific Meeting American College of Rheumatology/ARHP October 25–30, 2013, San Diego, USA

29. Mostafa N, Eckert D, Pradhan R, Mensing S, Robinson A, Sandborn W, Hanauer S, Colombel J, Thakkar R, Awni W. Exposure-Efficacy Relationship for Adalimumab during Induction Phase of Treatment of Adult Patients with Moderate to Severe Ulcerative Colitis. 21st Annual Conference United European Gastroenterology Week October 12 – 16, 2013, Berlin, Germany

30. Mostafa N, Lin C-W, Kaefer A, Coll B, Andress D, Brennan J, Klein C, Awni W. Exposure-Response Relationship for Atrasentan in Patients with Diabetic Nephropathy. - Kidney Week 2013 American Society of Nephrology November 5-10, 2013, Atlanta Georgia, USA

31. Awni M, Eckert D, Sharma S, Mostafa N, Noertersheuser P, Pradhan R, Robinson A, Sandborn W, Hanauer S, Colombel JF, Thakkar R. Pharmacokinetics of Adalimumab in Adult Patients with Moderately to Severely Active Ulcerative Colitis. 8th Congress of ECCO (European Crohn’s and Colitis Organization), Feb 14-16, 2013, Vienna/Austria; Abstract#-902/Poster #P412; and DDW (Digestive Disease Week) May 18-21, 2013, Orlando, Florida; Abstract#1603631.

32. Eckert D, Mensing S, Sharma S, Thakkar R, Robinson A, Hyams J, Rosh J, Ruemmele F, Awni W. Pharmacokinetics of Adalimumab in Pediatric Patients with Moderate to Severe Crohn's Disease. 8th Congress of ECCO (European Crohn’s and Colitis Organization), Feb 14-16, 2013, Vienna/Austria; Abstract#-904/Poster #P411; and DDW (Digestive Disease Week) May 18-21, 2013, Orlando, Florida; Abstract#1603658.

33. Noertersheuser P, Eckert D, Sharma S, Thakkar R, Robinson A, Sandborn W, Hanauer S, Colombel JF, Awni W. Factors Affecting Adalimumab Pharmacokinetics in Adult Patients with Moderate to Severe Crohn's Disease. 8th Congress of ECCO (European Crohn’s and Colitis Organization), Feb 14-16, 2013, Vienna/Austria; Abstract#-


882/Poster #P493; and DDW (Digestive Disease Week) May 18-21, 2013, Orlando, Florida; Abstract#1603541.

34. Pradhan R, Sharma S, Thakkar R, Robinson A, Hyams J, Rosh J, Ruemmele F, Awni W. Relationship between Adalimumab Concentration and Efficacy for the Induction of Clinical Remission in Pediatric Patients with Moderate to Severe Crohn's Disease. 8th Congress of ECCO (European Crohn’s and Colitis Organization), Feb 14-16, 2013, Vienna/Austria; Abstract#-1005/Poster #P385; and DDW (Digestive Disease Week) May 18-21, 2013, Orlando, Florida; Abstract#1603696.

35. Sharma s, Pradhan R, Thakkar R, Robinson A, Hyams J, Rosh J, Ruemmele F, Awni W. Relationship between Adalimumab Concentration and Efficacy for the Maintenance of Clinical Remission in Pediatric Patients with Moderate to Severe Crohn's Disease. 8th Congress of ECCO (European Crohn’s and Colitis Organization), Feb 14-16, 2013, Vienna/Austria; Abstract#-1013/Poster #P384; and DDW (Digestive Disease Week) May 18-21, 2013, Orlando, Florida; Abstract#1603725.

36. Mostafa N, Eckert D, Pradhan R, Mensing S, Robinson A, Sandborn W, Hanauer S, Colombel JF, Thakkar R, Awni W. Exposure-Efficacy Relationship (ER) for Adalimumab during Induction Phase of Treatment of Adult Patients with Moderate to Severe Ulcerative Colitis. DDW (Digestive Disease Week) May 18-21, 2013, Orlando, Florida; Abstract#1599083.

37. Khatri A, Liu W, Awni W, Dutta S: A semi-physiologic population PK/PD model for characterizing the effect of drug a on the diurnal changes in biomarker levels. American College of Clinical Pharmacology 41st Annual Meeting, September 23-25, 2012, San Diego, California.

38. Othman AA, Garimella T, Dutta S, Awni W, Mandema J: Quantitative clinical profiles of drugs evaluated for treatment of diabetic neuropathic pain: model-based meta analyses of efficacy and safety from randomized controlled clinical trials. American College of Clinical Pharmacology 41st Annual Meeting, September 23-25, 2012, San Diego, California.

39. Khatri A, Gaultier I, Menon RM, Marbury T, Lawitz E, Podsadecki T, Mullally V, Awni W, Bernstein B, Dutta S. Pharmacokinetics and Safety of Co-administered ABT-450 plus Ritonavir (ABT-450/r), ABT-267 and ABT-333 as a Single Dose in Subjects with Normal Hepatic Function and in Subjects with Mild, Moderate and Severe Hepatic Impairment. AASLD 2012 (Distinguished poster award)

40. Menon R, Klein C, Podsadecki T, Xiong J, Dutta S, Awni W, Bernstein B. Pharmacokinetics, safety and tolerability following multiple dosing of polymerease inhibitor, ABT-333 and protease inhibitor, ABT-450 with ritonavir, 7th International Workshop on Clinical Pharmacology of Hepatitis Therapy, 27 - 28 June 2012, Cambridge MA.

41. Dumas E, Kapoor M, Menon R, Gulati P, Campbell A, Williams L, Bernstein B, Awni W, Dutta S. Pharmacokinetics, safety, and tolerability of the NS5A inhibitor, ABT-267 in healthy Caucasian, Japanese, and Chinese subjects, 7th International Workshop on Clinical Pharmacology of Hepatitis Therapy, 27 - 28 June 2012, Cambridge MA.

42. Menon R, Kapoor M, Dumas E, Badri P, Campbell A, Gulati P, Bernstein B, Williams L, Awni W, Dutta S. Multiple-dose pharmacokinetics and safety following coadministration


of ABT-450/r, ABT-267 and ABT-333 in Caucasian, Japanese and Chinese subjects, 7th International Workshop on Clinical Pharmacology of Hepatitis Therapy, 27 - 28 June 2012, Cambridge MA.

43. Klein CE, Noertersheuser P, Mensing S, Meyer C, Teuscher N, Dumas EO, Awni WM. Exposure-Response Analyses of Bardoxolone Methyl Safety and Efficacy and Clinical Trial Simulations to Inform Phase III Dose Selection. The 49th European Renal Association - European Dialysis and Transplant Association. (ERA-EDTA) Congress, May 24-27, 2012, Paris, France - Poster#SAP256.

44. Othman AA, Dutta S, Awni WM, Mandema JW. Efficacy of pregabalin, gabapentin and duloxetine in treatment of diabetic neuropathic pain, postherpetic neuralgia and fibromyalgia: a model-based meta-analysis. American College of Clinical Pharmacology Annual Meeting, September 11-13, 2011, Chicago, IL. Abstract # 1123347 published in J Clin Pharmacol 2011;51(9):1351.

45. Othman AA, Nada A, Chiu Y, Pradhan R, Awni W, Dutta S. Non-linear mixed-effects model-based characterization of the variability in heart rate, blood pressure and QTc interval for healthy subjects treated with placebo in single dose phase 1 trials. American College of Clinical Pharmacology Annual Meeting, September 11-13, 2011, Chicago, IL. Abstract # 1123398 published in J Clin Pharmacol 2011;51(9):1352.

46. Nada A, Chiu Y, Othman AA, Chuang T, Dutta S, Pradhan R, Awni W. Profiling electrocardiogram (ECG) and vital signs parameters in 417 healthy volunteers receiving placebo. American College of Clinical Pharmacology Annual Meeting, September 11-13, 2011, Chicago, IL. Abstract # 1122898 published in J Clin Pharmacol 2011;51(9):1347.

47. Othman AA, Garimella T, Dutta S, Awni WM, Mandema JW. Non-linear mixed-effects model-based meta-analyses of the efficacy at end-of-trials for drugs evaluated for treatment of diabetic neuropathic pain. American Conference on Pharmacometrics, April 3-6, 2011, San Diego, CA.

48. Garimella T, Othman AA, Dutta S, Awni WM, Mandema JW. Meta-analyses of adverse events and dropout in diabetic neuropathic pain trials. American Conference on Pharmacometrics, April 3-6, 2011, San Diego, CA.

49. Hruska M, Paulson S, Kaul M, Awni W, Noertersheuser P. The population pharmacokinetics of briakinumab in subjects with moderate to severe plaque psoriasis. Annual Meeting of the Society for Investigative Dermatology, May 4-7, 2011, Phoenix, AZ. Abstract published in J Invest Dermatol 2011;131(Suppl. 1):S93.

50. Dumas D, Lawal A, Menon R, Podsadecki T, Awni W, Dutta S, Williams L. Pharmacokinetics, safety and tolerability of the HCV NS5A inhibitor ABT-267 following single and multiple doses in healthy adult volunteers. J Hepatol 2011; 54 (Suppl. 1):S3475.

51. Xiong H, Chiu YL, Pradhan RS, Li X, Carlson DM, Awni WM. Assessment of the effect of ethnicity on linifanib tolerability and pharmacokinetics in patients with cancer. J Clin Oncol 2011; 29 (suppl; abstr e13082)

52. Xiong H, Pradhan RS, Nada A, Krivoshik A, Holen K, Gordon G, Awni W, Humerickhouse R. Ethical Considerations in Evaluating Targeted Anti-Cancer Drug


Candidates in Healthy Volunteers – Safety and Risk Assessments. 102nd Annual Meeting of American Association for Cancer Research, Orlando, FL, April 2-6, 2011.

53. Yang J, Xiong H, Krivoshik A, Holen K, Pradhan RS, Chiu YL, Nada A, Tolcher A, Awni W, Humerickhouse R. Evaluating the Relative Bioavailability of a New formulation of Navitoclax (ABT-263) in both Cancer Patients and Healthy Subjects. 102nd Annual Meeting of American Association for Cancer Research, Orlando, FL, April 2-6, 2011.

54. Othman AA, Awni WM, Dutta S. Population pharmacokinetics of the TRPV-1 antagonist, ABT-102, in healthy human volunteers. American College of Clinical Pharmacology Annual Meeting, Baltimore, MD, September 12-14, 2010. Abstract #7 published in J Clin Pharmacol 2010;50(9):1059.

55. Othman AA, Nothaft W, Awni WM, Dutta S. Exposure-response analysis of the transient effect of the TRPV-1 antagonist, ABT-102, on body temperature in healthy human volunteers. American College of Clinical Pharmacology Annual Meeting, Baltimore, MD, September 12-14, 2010. Abstract #29 published in J Clin Pharmacol 2010;50(9):1063.

56. Othman AA, Nothaft W, Awni WM, Dutta S. Exposure-response analyses of the effects of the TRPV-1 antagonist, ABT-102, on thermal sensation in healthy human volunteers. American College of Clinical Pharmacology Annual Meeting, Baltimore, MD, September 12-14, 2010. Abstract #30 published in J Clin Pharmacol 2010;50(9):1063.

57. Xiong H, Garimella T, Locke C, Awni W, Dutta S. Single-dose pharmacokinetics and tolerability of ABT-089, a novel neuronal nicotinic receptor partial agonist, in healthy volunteers. American College of Clinical Pharmacology Annual Meeting, Baltimore, MD, September 12-14, 2010. Abstract published in J Clin Pharmacol 2010;50(9):1068.

58. Garimella T, Awni W, Yan J, Florian H, Dutta S. A multiple once daily dose, double-blind, placebo-controlled study of the pharmacokinetics and tolerability of ABT-089, a novel neuronal nicotinic receptor partial agonist, in healthy volunteers. American College of Clinical Pharmacology Annual Meeting, Baltimore, MD, September 12-14, 2010. Abstract published in J Clin Pharmacol 2010;50(9):1068.

59. Garimella T, Xiong H, Locke C, Awni W, Dutta S. Pharmacokinetics and tolerability of ABT-089, a novel neuronal nicotinic receptor partial agonist, in healthy volunteers, following multiple twice daily doses. American College of Clinical Pharmacology Annual Meeting, Baltimore, MD, September 12-14, 2010. Abstract published in J Clin Pharmacol 2010;50(9):1067

60. Garimella T, Lenz R, Locke C, Awni W, Dutta S. Pharmacokinetics and tolerability of ABT-089, a novel neuronal nicotinic receptor partial agonist, in elderly subjects, following multiple twice daily doses. American College of Clinical Pharmacology Annual Meeting, Baltimore, MD, September 12-14, 2010. Abstract published in J Clin Pharmacol 2010;50(9):1067.

61. Menon R, Cohen D, Awni W, Chiu YL, Klein C. Pharmacokinetics of the HCV polymerase inhibitor ABT-333 in US and Japanese healthy volunteers. 45th Annual Meeting of the European Association for the Study of the Liver, Vienna, Austria, April 14-18, 2010. Abstract published in J Hepatol 2010;52(Suppl. 1):S394.


62. Mensing S, Menon R, Klein C, Diderichsen P, Kaefer A, Noertersheuser P, Awni W. Exposure viral response analyses of the non-nucleoside polymerase inhibitor ABT-333 following monotherapy and ABT-333 plus pegylated interferon and ribavirin therapy. 45th Annual Meeting of the European Association for the Study of the Liver, Vienna, Austria, April 14-18, 2010. Abstract published in J Hepatol 2010;52(Suppl. 1):S393-S394.

63. Dumas E, Awni W, Cohen D, Bernstein B, Nada A, Chiu YL, Klein C. Pharmacokinetics of the HCV polymerase inhibitor ABT-072 following single and multiple dosing in healthy adult volunteers. 45th Annual Meeting of the European Association for the Study of the Liver, Vienna, Austria, April 14-18, 2010. Abstract published in J Hepatol 2010;52(Suppl. 1):S291.

64. Goss SL, Redden L, Bain E, Awni W, Dutta S. Nonlinear mixed-effects model of concentration-receptor occupancy relationship of a novel D3 receptor antagonist, ABT-925, in healthy subjects. 111th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics, Atlanta, GA, March 17 -20, 2010. Abstract published in Clin Pharmacol Ther 2010;87(Suppl. 1):S59-S60.

65. Zhu T, Williams L, Awni W, Smith W, Locke C, Pradhan R. Pharmacokinetics (PK) of fenofibric acid and rosuvastatin in subjects with mild to moderate renal impairment. 111th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics, Atlanta, GA, March 17-20, 2010. Abstract published in Clin Pharmacol Ther 2010;87(Suppl. 1):S27.

66. Zhu T, Awni W, Locke C, Wang Y, Tang E, Williams L, Heneghan G, Pradhan R. Biopharmaceutic strategy for developing a fixed-dose combination (FDC) product. 111th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics, Atlanta, GA, March 17 -20, 2010. Abstract published in Clin Pharmacol Ther 2010;87(Suppl. 1):S27.

67. Mandema JW, Pradhan RS, Thakker KM, Padley RJ, SleepDJ, Awni WM. Clinical benefit of reduction in LDL and triglycerides: meta-analyses of major coronary events. AHA Quality of Care and Outcomes Research in Cardiovascular Disease, Washington DC, May 19-21, 2010.

68. Gupta N, Palaparthy R, Awni W, Carlson D, Pradhan R. Assessment of pharmacokinetic (PK) interactions between Carboplatin (C), Paclitaxel (P) and ABT-869 in patients with advanced or metastatic non-small cell lung cancer (NSCLC). 13th World Conference on Lung Cancer, San Francisco, CA, October 2, 2009. J Thorac Oncol 2009;4(9,Suppl. 1): AbsP1-153.

69. Paulson S, Valdes J, Hruska M, Awni W. The pharmacokinetics of the fully human, interleukin-12/-23 monoclonal antibody (ABT-874) in normal healthy volunteers. J Am Acad Dermatol 2009;60(3):AbsP3325.

70. Zhang W H, Pradhan R, Thakkar R, Awni W. The hemodynamic impact of a loading dose preceding a 24-h continuous infusion of levosimendan in patients with acute heart failure. 7th Spring Conference of Clinical Pharmacy, Edinburgh, UK, May 16, 2007. Pharm World Sci 2009;31(1):139-140.

71. Pradhan R, Noertersheuser P, Zhang W H, Delgado-Herrera L, Thakkar R, Awni W. Levosimendan population pharmacokinetic/pharmacodynamic model predicts


hemodynamic responses in patients with acute heart failure. 7th Spring Conference of Clinical Pharmacy, Edinburgh, UK, May 16, 2007. Pharm World Sci 2009;31(1): AbsPT-325.

72. Pradhan R, Zhang WH, Noertersheuser P, Thakkar R, Awni W. Levosimendan affects hemodynamic responses in a simple e-max and dose-dependent manner in patients with acute heart failure. 7th Spring Conference of Clinical Pharmacy, Edinburgh, UK, May 16, 2007. Pharm World Sci 2009;31(1): AbsPT-324.

73. Pradhan R, Noertersheuser P, Zhang WH, Awni W. Acetylation status has no impact on the hemodynamic effects of levosimendan. 7th Spring Conference of Clinical Pharmacy, Edinburgh, UK, May 16, 2007. Pharm World Sci 2009;31(1): AbsPT-305.

74. Ng J, Noertersheuser PA, Mensing S, Awni WA, Klein CE. Population pharmacokinetic analysis of lopinavir and ritonavir in HIV-1 treatment-experienced subjects receiving the lopinavir/ritonavir tablet formulation. 12th European AIDS Conference, Cologne, Germany, November 11-14, 2009. Poster PE4.1/4.

75. Xiong H, Noertersheuser PA, Pradhan RS, Mittelstadt S, Marsh KC, Humerickhouse R, Awni W. Exposure-response (E-R) relationship in ABT-263-induced thrombocytopenia and the effect of platelet transfusion in dogs. EORTC-NCI-AACR Molecular Targets and Cancer Therapeutics Meeting, Boston, MA, November 18, 2009.

76. Xiong H, Noertersheuser PA, Pradhan RS, Krivoshik AP, Humerickhouse R, Awni W. Exposure-response (E-R) relationship of ABT-263-induced thrombocytopenia in cancer patients in Phase 1 studies. EORTC-NCI-AACR Molecular Targets and Cancer Therapeutics Meeting, Boston, MA, November 15, 2009.

77. Chiu Y, Yan Z, Gupta N, Diderichsen P, Carson D, Pradhan R, Awni W. Exposure-response analysis to identify ABT-869 dose in hepatocellular carcinoma (HCC) patients. 15th Congress of the European Cancer Organization/34th Multidisciplinary Congress of the European Society for Medical Oncology, Berlin, Germany, September 20-24, 2009. EJC Supplements 2009;7(2):394.

78. Menon R, Cohen D, Nada A, Chiu YL, Podsadecki T, Awni W, Bernstein B, Klein C. Pharmacokinetics, safety and tolerability of the HCV polymerase inhibitor ABT-333 following multiple ascending doses and effect of co-administration of ketoconazole in healthy subjects. 44th Annual Meeting of the European Association for the Study of the Liver, Copenhagen, Denmark, April 22-26, 2009. Abstract published in J Hepatol 2009;50(Suppl. 1):S348.

79. Menon R, Cohen D, Nada A, Dumas E, Chiu YL, Podsadecki T, Awni W, Bernstein B, Klein C. Pharmacokinetics, tolerability and effect of food on HCV polymerase inhibitor ABT-333 following single ascending doses in healthy volunteers. 44th Annual Meeting of the European Association for the Study of the Liver, Copenhagen, Denmark, April 22-26, 2009. Abstract published in J Hepatol 2009;50(Suppl. 1):S347-S348.

80. Yan Z, Hosmane B, Chiu Y, Awni W, Locke C. First in human study design considerations. 110th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics, National Harbor, MD, March 18 -29 2009. Abstract published in Clin Pharmacol Ther 2009;85(Suppl. 1):S22-S23.


81. Dutta S, Awni W. Population pharmacokinetics of ABT-594 in subjects with diabetic peripheral neuropathic pain. American Conference on Pharmacometrics, October 4-7, 2009, Mystic, CT. Abstract #S5 & poster are available from: http://www.go-acop.org/acop2009/posters.

82. Diderichsen PM, Dutta S, Liu W, Noertersheuser PA, Awni W. Modeling “pain memory” is central to characterizing the hazard of dropping out in acute pain studies. American Conference on Pharmacometrics, October 4-7, 2009, Mystic, CT. Abstract #P8 & poster are available from: http://www.go-acop.org/acop2009/posters.

83. Liu W, Diderichsen PM, Noertersheuser PA, Awni W, Dutta S. Time-dependent, dual first- and zero-order absorption model for characterizing delayed absorption profile in subjects with acute pain. American Conference on Pharmacometrics, October 4-7, 2009, Mystic, CT. Abstract #P7 & poster are available from: http://www.go-acop.org/acop2009/posters.

84. Garimella T, Lenz R, Awni W, Dutta S. Population pharmacokinetic analysis of ABT-089, a neuronal nicotinic receptor agonist, in elderly subjects with Alzheimer’s disease and in healthy adult subjects. American Conference on Pharmacometrics, October 4-7, 2009, Mystic, CT. Abstract #R8 & poster are available from: http://www.go-acop.org/acop2009/posters.

85. Dutta S, Hosmane BS, Awni W. Population analyses of efficacy and safety of ABT-594 in subjects with diabetic peripheral neuropathic pain. American Conference on Pharmacometrics, October 4-7, 2009, Mystic, CT. Abstract #S6 & poster are available from: http://www.go-acop.org/acop2009/posters.

86. Klein CE, Cohen D, Menon RM, Hazan L, Awni WA, Chiu YL, Dumas EO, Larsen LM, Podsadecki TJ, Nada A, Bernstein BM. Safety, tolerability, pharmacokinetics and antiviral activity of the HCV polymerase inhibitor ABT-072 following single and multiple dosing in healthy adult volunteers and two days of dosing in treatment-naïve HCV genotype 1-infected subjects. HEP DART 2009, Kohala Coast, HI, December 6-10, 2009. Global Antiviral Journal 2009;5(S1);52.

87. Menon RM, Klein CE, Lawal AA, Chiu YL, Awni WM, Podsadecki TJ, Nada A, Bernstein BM. Pharmacokinetics and tolerability of the HCV protease inhibitor ABT-450 following single ascending doses in healthy adult volunteers with and without ritonavir. HEP DART 2009, Kohala Coast, HI, December 6-10, 2009. Global Antiviral Journal 2009;5(S1);53.

88. Bernstein BM, Menon RM, Klein CE, Lawal AA, Nada A, Gaultier I, Podsadecki TJ, Awni WM. Pharmacokinetics, safety and tolerability of the HCV protease inhibitor ABT-450 with ritonavir following multiple ascending doses in healthy adult volunteers. HEP DART 2009, Kohala Coast, HI, December 6-10, 2009. Global Antiviral Journal 2009;5(S1);53.

89. Klein CE, Menon RM, Cohen DE, Awni WM, Bernstein BM. Pharmacokinetics of a polymerase inhibitor, ABT-333, in treatment-naïve genotype-1 HCV infected subjects following treatment with 2 days of ABT-333 followed by 26 days of ABT-333 plus pegylated interferon and ribavirin. HEP DART 2009, Kohala Coast, HI, December 6-10, 2009. Global Antiviral Journal 2009;5(S1);54.


90. Klein CE, Ng J, Chiu YL, Diderichsen PM, Da Silva B, Bernstein BM, Awni WM. Population pharmacokinetic/pharmacodynamic analyses of lopinavir and titonavir in subjects receiving the tablet formulation. Ninth International Congress on Drug Therapy in HIV Infection, Glasgow, UK, November 9-13, 2008. Abstract published in J Intl AIDS Soc 2008;11(Suppl. 1):P245.

91. Klein CE, Chiu YL, Awni W, Ng J, Cui Y, Morris J, Podsadecki TJ, Kim D, Bernstein BM. The effect of food on ritonavir bioavailability following administration of ritonavir 100 mg film-coated tablet in healthy adult subjects. Ninth International Congress on Drug Therapy in HIV Infection, Glasgow, UK, November 9-13, 2008. Abstract published in J Intl AIDS Soc 2008;11(Suppl. 1):P247.

92. Klein CE, Chiu YL, Da Silva BA, Noertersheuser PA, Awni WM, Holas CM, Doan TT, Bernstein BM. Evaluation of the impact of lopinavir/ritonavir (LPV/r) and ritonavir (RTV) on QTcF: results from a thorough QT study. Ninth International Congress on Drug Therapy in HIV Infection, Glasgow, UK, November 9-13, 2008. Abstract published in J Intl AIDS Soc 2008;11(Suppl. 1):P95.

93. Da Silva BA, Li J, Chiu YL, Noertersheuser PA, Awni WM, Klein CE, Doan TT, Bernstein BM. Evaluation of the impact of lopinavir/ritonavir (LPV/r) and ritonavir (RTV) on PR interval: results from a thorough QT study. Ninth International Congress on Drug Therapy in HIV Infection, Glasgow, UK, November 9-13, 2008. Abstract published in J Intl AIDS Soc 2008;11(Suppl. 1):P101.

94. Klein CE, Chiu YL, Awni WM, Ng J, Xiong J, Roth W, Podsadecki T, Kim D, Bernstein BM. A pivotal biostudy comparing ritonavir 100 mg film-coated tablet to a ritonavir 100 mg soft gelatin capsule in healthy adult subjects. XVII AIDS Conference, Mexico City, Mexico, August 3-8, 2008, THAB0405.

95. Zhu T, Pradhan R, Fang X, Locke C, Sleep D, Wan K, Awni W. Omeprazole has no effect on fenofibric acid absorption from ABT-335, a new modified-release formulation of fenofibric acid, in humans. 37th Annual Meeting of the American College of Clinical Pharmacology, Philadelphia, PA, September 14-16, 2008. Abstract published in J Clin Pharmacol 2008;48(9):1117.

96. Zhu T, Pradhan R, Fang X, Locke C, Sleep D, Wan K, Awni W. Effect of Food on Fenofibric Acid Absorption from ABT-335. 37th Annual Meeting of the American College of Clinical Pharmacology, Philadelphia, PA, September 14-16, 2008. Abstract published in J Clin Pharmacol 2008;48(9):1117.

97. Peng J, Noertersheuser P, Awni W, Paulson S. Predicting long-term efficacy of methotrexate in the treatment of moderate-to-severe psoriasis: a modeling and simulation approach. European Academy of Dermatology and Venereology Spring Meeting, Turkey, 2008.

98. Zhu T, Freeney T, Chiu YL, Heuser K, Pradhan R, Locke C, Awni W, Blakesley V. A novel DPP-IV inhibitor ABT-279 is safe and effective in healthy overweight subjects. American Diabetes Association (ADA) 67th Scientific Session, 2007. Diabetes 2007;56(Suppl. 1):A150.

99. Noertersheuser P, Pradhan R, Mandema J, Zhang W, Thakkar R, Awni W. Pharmacokinetics/pharmacodynamics meta-analysis for levosimendan in patients with


heart failure. American College of Clinical Pharmacology (ACCP) Annual Meeting, San Francisco, CA, 2007.

100. Pradhan R, Noertersheuser P, Zhang W, Awni W. Acetylation status has no impact on the hemodynamic effects of levosimendan. Annual Meeting of The European Society of Clinical Pharmacy, Edinburgh, Scotland, May 2007.

101. Pradhan R, Zhang W, Noertersheuser P, Thakkar R, Awni W. Levosimendan affects hemodynamic responses in a simple Emax and dose-dependent manner in patients with acute heart failure. Annual Meeting of The European Society of Clinical Pharmacy, Edinburgh, Scotland, May 2007.

102. Pradhan R, Noertersheuser P, Zhang W, Delgado-Herrera L, Thakkar R, Awni W. Levosimendan population pharmacokinetic/pharmacodynamic model predicts hemodynamic responses in patients with acute heart failure. Annual Meeting of The European Society of Clinical Pharmacy, Edinburgh, Scotland, May 2007.

103. Zhang W, Pradhan R, Thakkar R, Awni W. The hemodynamic impact of a loading dose preceding a 24-hour continuous infusion of levosimendan in patients with acute heart failure. Annual Meeting of The European Society of Clinical Pharmacy, Edinburgh, Scotland, May 2007.

104. Pradhan R, Noertersheuser P, Zhang W, Thakkar R, Awni W. Population Pharmacokinetics of levosimendan and its metabolites in patients with heart failure. Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics, 2007. Abstract published in Clin Pharmacol Ther 2007;81(Suppl. 1):S37.

105. Zhu T, Klein C, Awni W. Modeling the drug interaction of lopinavir/ritonavir with efavirenz. Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics, 2006. Abstract published in Clin Pharmacol Ther 2006;79(2):27.

106. Klein CE, Chiu YL, Bernstein B, Hanna GJ, Awni W. Predicted lopinavir and ritonavir pharmacokinetics of high dose lopinavir/ritonavir as the tablet formulation. 77th International Workshop on Clinical Pharmacology of HIV Therapy, April 2006, Abstract 87.

107. Chiu YL, Locke C, Klein CE, Hanna GJ, Brun S, Awni W. Assessment of pharmacokinetic variability for lopinavir/ritonavir (LPV/r) tablet and soft-gel capsule (SGC) formulations. 77th International Workshop on Clinical Pharmacology of HIV Therapy, April 2006, Abstract 78A&B.

108. Peng J, Pradhan R, Causemaker S, Achari R, Edeki T, Locke C, Santoro D, Walch J, Zhu , Blakesley V, Landschulz W, Awni W. Sibutramine and omeprazole: potential pharmacokinetic interaction. American Diabetes Association (ADA) 66th Scientific Session, 2006.

109. Zhu T, Pradhan R, Jurasz R, Achari R, Edeki T, Locke C, Santoro D, Walch J, Horn P, Blakesley V, Landschulz W, Awni W. Sibutramine and simvastatin: potential for pharmacokinetic interactions. American Diabetes Association (ADA) 66th Scientific Session, 2006.

110. Zhu T, Chiu Y, Doan T, Klein C, Chang M, Brun S, Hanna G, Awni W. New tablet formulation of lopinavir/ritonavir is bioequivalent to the capsule at a dose of 800/200 mg.


45th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC), December 2005. Poster H-1894.

111. Awni W, Chiu YL, Zhu T, Braun N, Klein C, Heuser R, Breitenbach J, Morris J, Doan T, Brun S, Hanna G. Significantly Reduced Food Effect and Pharmacokinetic Variability with a Novel Lopinavir/ritonavir Tablet Formulation. 3rd IAS Conference on HIV Pathogenesis and Treatment, Rio de Janeiro, Brazil, July 24-27, 2005. Oral Presentations and Poster WEOa0206.

112. Velagapudi R, Noertershauser P, Awni W, Granneman R, Kupper H. Bioavailability of adalimumab following subcutaneous injections in rheumatoid arthritis patients. Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics, 2005. Abstract published in Clin Pharmacol Ther 2005;77(2, Suppl. S):P84.

113. Klein C, Zhu T, Chiu Y, Doan T, Hanna G, Awni W, Brun S. Pharmacokinetic effect of efavirenz on a new tablet formulation of lopinavir/ritonavir. European AIDS Conference, Dublin, Ireland, November 17-20, 2005. PE4.3/2.

114. Zhang W, Pradhan R, Edeki T, Freeney T, Chiu W, Luo A, Awni W. An open-label, single-dose, sequential study to assess the potential pharmacokinetic interaction between ABT-578 and ketoconazole in healthy subjects. Annual Meeting of American Association of Pharmaceutical Sciences (AAPS), Nashville, TN, 2005.

115. Palaparthy R, Zhang W, Awni W, Pradhan R. Human pharmacokinetic predictions using pig post-coronary implantation blood concentration data for zotarolimus (ABT-578)-eluting stents. Annual Meeting of American Association of Pharmaceutical Sciences (AAPS), Nashville, TN, 2005.

116. Pradhan R, Noertersheuser P, Awni W. An in vitro in vivo correlation assessment for a drug (zotarolimus) eluting stent. Annual Meeting of American Association of Pharmaceutical Sciences (AAPS), Nashville, TN, 2005.

117. Palaparthy R, Pradhan R, Chan J, Rieser M, Titus C, Galitz L, Qiu P, Awni W, Williams L. Assessment of the single dose pharmacokinetics and safety of the co-administration of paricalcitol with omeprazole in healthy subjects. Annual Meeting of American Society of Nephrology (ASN), Philadelphia, PN, 2005.

118. Palaparthy R, Pradhan R, Chan J, Rieser M, Chiu W, Preston R, Qiu P, Awni W, Williams L. Safety and pharmacokinetics of paricalcitol capsules in CKD stage 3 and 4 subjects following every day dosing. Annual Meeting of American Society of Nephrology (ASN), Philadelphia, PN, 2005.

119. Velagapudi RB, Noertershauser PA, Awni W, Granneman GR, Chartash E. Adalimumab (HUMIRA) 40 mg every other week plus methotrexate in patients with rheumatoid arthritis provides stable serum concentrations and sustained efficacy over 1 year. EULAR Berlin, Germany, 2004. Abstract published in Annals of the Rheumatic Diseases 2004;63(Suppl I):267.

120. Velagapudi RB, Noertershauser PA, Awni W, Granneman GR, Kupper H. Bioavailability of adalimumab (HUMIRA) following subcutaneous injection in patients with rheumatoid arthritis using limited sampling approach. ACR, San Antonio, TX, 2004.


121. Velagapudi RB, Awni WM, Fischkoff SA, Kupper H, Granneman GR, van de Putte LBA, Keystone EC. Effect of methotrexate coadministration on the pharmacokinetics of adalimumab (HUMIRA) following a single intravenous injection. Arthritis & Rheumatism 2003;48(9):S141.

122. Granneman RG, Zhang Y, Noertershauser PA, Velagapudi RB, Awni WM, Locke CS, Fischkoff SA. Pharmacokinetics/pharmacodynamic (PK/PD) relationships of adalimumab (HUMIRA) in rheumatoid arthritis (RA) patients during Phase II/III clinical trials. Arthritis & Rheumatism 2003;48(9):S140-S141.

123. Awni WM, Cascella P, Oleka NA, Velagapudi RB, Kupper H, Chartash E, Granneman RG. Steady-state pharmacokinetics (PK) of adalimumab (HUMIRA) in rheumatoid arthritis (RA) patients with and without methotrexate (MTX) background therapy. Arthritis & Rheumatism 2003;48(9):S140.

124. Velagapudi RB, Noertershauser P, Bankmann Y, Granneman RG, Awni W, Chartash E. Pharmacokinetics of adalimumab (D2E7), a fully human anti-TNF-alpha monoclonal antibody, following a single intravenous injection in rheumatoid arthritis patients treated with methotrexate. Arthritis & Rheumatism 2002;46;S133.

125. Scandling J, Rajagopalan PR, Magee J, Conti D, Mendez R, Bronson D, Awni W, Nabulsi A, Hoffman R. A clinical experience with gengraf (Abbott cyclosporine) in de novo renal transplant recipients. Transplantation 2000;69:184.

126. Tomlanovich S, Roza A, Pollak R, Merion R, Wright F, Scandling J, Rajagopalan PR, Pruett T, Greco R, Awni W, Hoffman R, Nabulsi A. Assessment of demographic variables on the pharmacokinetics of Gengraf vs. Neoral in stable renal transplant recipients. Abstract published in J Amer Soc Nephrol September 2000:673A.

127. Tomlanovich S, Pollak R, Roza A, Merion R, Scandling J, Greco R, Dube L, Awni W, Nabulsi A. A pharmacokinetic conversation study of Abbott cyclosporine and Neoral in stable renal transplant recipients. 18th Annual Meeting of the American Society for Transplant Physicians, 1999. Abstract published in Transplantation 1999;67(7):S-163(#628).

128. Pollak R, Tomlanovich S, Roza A, Merion R, Scandling J, Greco R, Dube L, Awni W, Nabulsi A. Interchangeability of Abbott cyclosporine and Neoral in stable renal transplant recipients. 9th Congress of the European Society for Organ Transplantation, Oslo, Norway, June 1999 (#1082).

129. Kearns GL, Wong SL, Johnson K, Dowling P, Kemp JP, Drajesk J, Chang M, Dube L, Awni WM. Pharmacokinetics of a novel 5-lipoxygenase inhibitor (ABT-761) in pediatric patients with asthma. 99th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics Meeting, 1998. Abstract published in Clin Pharmacol Ther 1998;63(2):192.

130. Wong SL, O'Dea R, Dube L, Awni WM. Steady state effect of ABT-761 on the pharmacokinetics of ethinyl estradiol and levonorgestrel. 99th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics Meeting, 1998. Abstract published in Clin Pharmacol Ther 1998;63(2):163.

131. Wong SL, O'Dea R, Dube L, Awni WM. Single and multiple dose pharmacokinetics of ABT-761 in elderly male and female healthy volunteers. 13th Annual Meeting of the


American Association of Pharmaceutical Scientist Meeting, 1998. Abstract published in PharmSci Supplement 1998;1(1): S-465.

132. Awni WM, Wong W, Chu S-Y, Patterson K, Hansen R, Machinist JM, Drajesk J, Keane WF, Halstenson CE. Pharmacokinetics of zileuton and its metabolites in subjects with renal impairment. 98th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics, 1997. Abstract published in Clin Pharmacol Ther 1997;61:217.

133. Wong W, Cavanaugh JH, Qian J, Hansen R, Awni WM. Effect of ABT-761 on the pharmacokinetics of theophylline. 98th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics, 1997. Abstract published in Clin Pharmacol Ther 1997;61:158.

134. Awni WM, Cao G, Kasier JF, Locke CS, Machinist JM, Dube LM. The Pharmacokinetic/pharmacodynamic interaction between zileuton and terfenadine. 97th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics, 1996. Abstract published in Clin Pharmacol Ther 1996;59:203.

135. Hui H-W, Awni WM, Qiu Y, Semla S, Papp K, Cheskin H. Controlled release of zileuton from monolith matrix tablets: in vitro studies and in vivo evaluation in healthy volunteers. Annual Meeting of the American Association of Pharmaceutical Scientists, 1996. Abstract published in Pharm Res 1996;13(9, Suppl):S-289

136. Coleman D, Awni W, Kelly HW, Mcwilliams BC, Bialek-Smith S, Dube L. Initial pharmacokinetics evaluation of zileuton in asthmatic children. Annual Meeting of the American Thoracic Society, 1995. Abstract published in Am J Respiratory and Critical Care Medicine 1995;151(4, Suppl):A377.

137. Awni W, Cao G, Locke C. Population modeling of leukotriene B4 (LTB4) inhibition by zileuton in asthmatic children. Annual Meeting of The American Association of Pharmaceutical Scientists, 1995. Abstract published in Pharm Res 1995;12(9,Suppl):S-362.

138. Wong SL, Sebree T, Awni WM, Granneman GR. Nonlinear pharmacokinetics of sertindole, a new anti-psychotic compound. Annual Meeting of the American Association of Pharmaceutical Scientists, 1995. Abstract published in Pharm Res 1995;12(9, Suppl):S-391.

139. Wong SL, Sebree T, Awni WM, Granneman GR. Analysis of pharmacodynamics and concentration relationship of sertindole, a new anti-psychotic compound using NONMEM. Annual Meeting of the American Association of Pharmaceutical Scientists, 1995. Abstract published in Pharm Res 1995;12(9, Suppl):S-361.

140. Awni WM, Cavanaugh JH, Granneman GR, Schneck DW, Dube LM. Diurnal variation in the pharmacokinetics of zileuton in humans. 95th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics, 1994. Abstract published in Clin Pharmacol Ther 1994;55:199.\

141. Awni WM, Cohn J, Lanni C, Dube L, and The Leutrol Study Group. The relationship of zileuton pharmacokinetics and pharmacodynamics as assessed by inhibition of leukotriene B4 biosynthesis and improvement in pulmonary function in patients with


moderate asthma. Annual Congress of the European Respiratory Society, Nice, France, 1994. Abstract published in European Respiratory Journal 1994;7( Suppl 18):152s.

142. Wong SL, Locke C, Granneman GR, Awni WM. Comparison between a sequential NONMEM PK/PD analysis approach versus separate PK and PD analysis for a drug producing ex-vivo LTB4 inhibition. Annual Meeting of the American Association of Pharmaceutical Scientists, 1994. Abstract published in Pharm Res 1994;11(10,Suppl):S-379.

143. Wong SL, Granneman GR, Awni WM. Application of population approach in evaluating the effects of food and formulation on the pharmacokinetic parameters from a bioavailability study. Annual Meeting of the American Association of Pharmaceutical Scientists, 1994. Abstract published in Pharm Res 1994;11(10, Suppl):S-433.

144. Wong SL, Locke C, Dube L, Granneman GR, Awni WM. Meta-analysis of the pharmacodynamic relationship between the ex vivo LTB4 inhibition in whole blood and zileuton plasma concentrations from Phase I studies in normal volunteers using NONMEM approach. Annual Meeting of the American Association of Pharmaceutical Scientists, 1994. Abstract published in Pharm Res 1994;11(10, Suppl):S-434

145. Granneman GR, Carlson G, Cavanugh JH, Awni WM, Wong SL. Modeling the extent of amitriptyline and nortriptyline metabolic inhibition during valproate coadministration. Annual Meeting of the American Association of Pharmaceutical Scientists, 1994. Abstract published in Pharm Res 1994;11(10, Suppl):S-434.

146. Lanni C, Wong S, Chang M, Hansen S, Robbins D, Drajesk J, Hansen RG, Awni WM, Dube L. Pharmacokinetics and pharmacodynamics of a 5-lipoxygenase inhibitor, ABT-761, in normal volunteers. 7th International Conference of the Inflammation Research Association, 1994.

147. Awni WM, Granneman GR, Locke C, Dube LM, Brandwein S, Rubin P. Population pharmacokinetics of zileuton in patients with rheumatoid arthritis. Annual Meeting of the American Association of Pharmaceutical Scientists, 1993. Abstract published in Pharm Res 1993;10(10, Suppl):S-401.

148. Awni WM, Heim-Duthoy KL. A novel approach for therapeutic monitoring of cyclosporine: estimation of average steady-state concentrations by a single pooled blood sample. 93rd Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics, 1992. Abstract published in Clin Pharmacol Ther 1992;51:137.

149. St. Peter JV, Halstenson CE, Awni WM. Inter and intrasubject variability in antipyrine plasma and urine metabolite disposition. 93rd Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics, 1992. Abstract published in Clin Pharmacol Ther 1992;51:178.

150. Hirata-Dulas CAI, Awni WM, Weliky I, Halstenson CE. Disposition of azelastine and desmethylazelastine in patients with hepatic dysfunction and renal impairment. Annual Meeting of the American Association of Pharmaceutical Scientists, 1992. Abstract published in Pharm Res 1992;9(10, Suppl):S-318.

151. Halstenson CE, Shapiro BE, Hoff JV, Awni WM. A dose ranging pharmacokinetics study of sodium diethyldithiocarbamate (DDTC) in normal healthy volunteers. Annual


Meeting of the American Association of Pharmaceutical Scientists, 1992. Abstract published in Pharm Res 1992; 9(10, Suppl):S-317.

152. Shaker M, Tritschler D, Bushman L, Awni W. A rat aortic transplant model for studying drug metabolism and pharmacokinetics during chronic rejection. Annual Meeting of the American Association of Pharmaceutical Scientists, 1992. Abstract published in Pharm Res 1992; 9(10, Suppl):S-287.

153. Halstenson CE, Heim-Duthoy KL, Teal MA, Affrime MB, Kelloway JH, Shapiro BE, Awni WM. Effect of concomitant administration of piperacillin on the disposition of isepamicin in patients with end-stage renal disease. 31th Annual ICAAC Meeting, 1991.

154. Hirata-Dulas CAI, Guay DRP, Matzke GR, Keane WF, Halstenson CE, Awni WM. Comparison of three clearance techniques for measuring renal plasma flow. 12th Annual Meeting of the American College of Clinical Pharmacy, 1991. Abstract published in Pharmacotherapy 1991;11(3):281.

155. Awni WM, St. Peter JV, Brady ME, Dandekar KA, Halstenson CE. Effect of batanopride on antipyrine metabolism in healthy subjects. Annual Meeting of the American Association of Pharmaceutical Scientists, 1991. Abstract published in Pharm Res 1991;8(10, Suppl):S-293.

156. Awni WM, St. Peter JV, Halstenson CE. Comparative metabolic profiles of antipyrine in rat, rabbit and human. Annual Meeting of the American Association of Pharmaceutical Scientists, 1991. Abstract published in Pharm Res 1991;8(10, Suppl):S-319.

157. Awni WM, Tritschler DD, Kasiske BL. The effect of fish oil as compared to olive oil on cyclosporine bioavailability and disposition in rats. Annual Meeting of the American Association of Pharmaceutical Scientists, 1991. Abstract published in Pharm Res 1991;8(10, Suppl):S-253.

158. Kasiske BL, Tortorice KL, Heim-Duthoy K, Awni WM, Rao KV. Possible impact of low density lipoprotein (LDL) on renal transplant acute rejection. 22nd Annual Meeting of the American Society of Nephrology, 1989. Abstract published in Kidney Int 1990;37:608.

159. Awni, WM. The impact of lipoproteins moieties on drug levels and biological activity in renal and hepatic transplant patients. Invited speaker to The International Meeting on Cyclosporine Therapeutic Drug Monitoring, Hawk's Cay, FL, January 1990.

160. Awni, WM. Serial post-transplant cyclosporine monitoring in renal transplant patients. Invited speaker to The International Meeting on Cyclosporine Therapeutic Drug Monitoring, Hawk's Cay, FL, January 1990.

161. St. Peter JV, Halstenson CE, Keane WF, Awni WM. Antipyrine plasma and urine metabolite disposition with lorazepam coadministration. 91st Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics, 1990. Abstract published in Clin Pharmacol Ther 1990;47:158.

162. St. Peter WL, Awni WM, Matzke GR, Thompson GA. Multiple-dose teicoplanin pharmacokinetics in infected hemodialysis patients utilizing a new fluorescence polarization immunoassay (FPIA). 11th Annual Meeting of the American College of Clinical Pharmacy, 1990. Abstract published in Pharmacotherapy 1990;10:239.


163. Halstenson CE, Shepard JH, Shapiro BE, Keane WF, Holland M, Affrime MB, Lin C, Awni WM. Disposition of isepamicin in hemodialysis patients. 11th Annual Meeting of the American College of Clinical Pharmacy, 1990. Abstract published in Pharmacotherapy 1990;10:239.

164. Tortorice KL, Heim-Duthoy KL, Kasiske BL, Awni WM. Monitoring of cyclosporine (CsA) metabolite levels: relationship between trough levels and dose in renal transplant recipients. 11th Annual Meeting of the American College of Clinical Pharmacy, 1990. Abstract published in Pharmacotherapy 1990;10:248.

165. Heim-Duthoy KL, Tortorice KL, Kasiske BL, Awni WM. Impact of cyclosporine pharmacokinetics on dosing frequency in renal transplant recipients. 11th Annual Meeting of the American College of Clinical Pharmacy, 1990. Abstract published in Pharmacotherapy 1990;10:249.

166. St. Peter JV, Abul-Hajj Y, Awni WM. Pharmacokinetics of antipyrine and three preformed metabolites in the rabbit. Annual Meeting of the American Association of Pharmaceutical Scientists, 1990. Abstract published in Pharm Res 1990;7(suppl):S-265.

167. Awni WM, Gisbert V, Smith CS. Effect of ischemia on the distribution of cyclosporine and its metabolites in rats. Annual Meeting of the American Association of Pharmaceutical Scientists, 1990. Abstract published in Pharm Res 1990;7(suppl):S-233.

168. Awni WM, Tritschler DD. Measurement of antipyrine and its three main metabolites in plasma and urine by HPLC. Annual Meeting of the American Association of Pharmaceutical Scientists, 1990. Abstract published in Pharm Res 1990;7(suppl):S-9.

169. Railker AM, Awni WM, Camp RJ, Rahman YE. Studies on an oral iron chelator: 1,2 dimethyl 3-hydroxy-pyrid-4-one (DMHP). Mechanism of intestinal absorption. Annual Meeting of the American Association of Pharmaceutical Scientists, 1990. Abstract published in Pharm Res 1990;7(suppl):S-157.

170. Kelloway JS, Awni WM, Lin C, Lin J, Affrime MB, Keane WF, Matzke GR, Halstenson CE. Ceftibuten disposition in patients with various degrees of renal function. 30th Annual ICAAC Meeting, 1990.

171. Halstenson C, Kelloway J, Shapiro B, Lin C, Keane W, Teal M, Affrime M, Awni W. Disposition of isepamicin in patients with various degrees of renal function. 30th Annual ICAAC Meeting, 1990.

172. Guay DRP, Hirata CA, Stein DJ, Awni WM. Pharmacokinetics of ciprofloxacin in elderly patients with lower respiratory tract infections at steady state after intravenous and oral administration. 90th Annual Meeting of the American Society of Clinical Pharmacology and Therapeutics, 1989. Abstract published in Clin Pharmacol Ther 1989;45:162.

173. Kasiske BL, Awni WM, Heim-Duthoy KL, Tortorice KL, Rao KV, Keane WF. Lipid metabolism in renal transplantation: relationship to vascular injury and cyclosporine. Nutrient Modulation of Progressive Renal Injury Symposium, Airlie, VA, 1989.

174. Tortorice KL, Heim-Duthoy KL, Kasiske BL, Awni WM. Influence of anthropometric dose correction on cyclosporine pharmacokinetics. 10th Annual Meeting of the American College of Clinical Pharmacy, 1989. Abstract published in Pharmacotherapy 1989;9:193.


175. Rybak MJ, Reddy VN, Matzke GR, Awni WM, St. Peter W, Martin SH, Mayer GD, Kenny MT, and FPIA Study Group. Teicoplanin fluorescence polarization immunoassay (FPIA). 10th Annual Meeting of the American College of Clinical Pharmacy, 1989. Abstract published in Pharmacotherapy 1989;9:188.

176. Awni WM, Heim-Duthoy KL, Kasiske BL. Renal clearances of cyclosporine and three of its metabolites in renal transplant patients. IV World Conference on Clinical Pharmacology and Therapeutics, 1989. Abstract published in Eur J Clin Pharmacol 1989;36:A127.

177. Heim-Duthoy KL, Tortorice KL, Peltier GL, Matzke GR, Awni WM. Pharmacokinetics of intravenous and oral enoxacin in patients with serious infections. 29th Annual ICAAC Meeting, 1989.

178. St. Peter WL, Guay DRG, Matzke GR, Kenny MT, Awni WM. Comparison of high performance liquid chromatography, fluorescence polarization immunoassay and microbiological assay for the determination of teicoplanin in dialysis patients. 29th Annual ICAAC Meeting, 1989.

179. Awni WM, Maloney JA. High performance liquid chromatographic analysis of isepamicin in plasma, urine and dialysate. Annual Meeting of the American Association of Pharmaceutical Scientists, 1989. Abstract published in Pharm Res 1989;6:S5.

180. Awni WM, Burometto CA, Guay DRP. Unidirectional transport of teicoplanin from peritoneal fluid to plasma in continuous ambulatory peritoneal dialysis (CAPD) patients. Annual Meeting of the American Association of Pharmaceutical Scientists, 1989. Abstract published in Pharm Res 1989;6:S219.

181. Halstenson CE, Awni WM, Hirata CA, Matzke GR, Keane WF. Comparative liver function assessment in subjects with renal impairment, normal and impaired hepatic function. Annual Meeting of the American Association of Pharmaceutical Scientists, 1989. Abstract published in Pharm Res 1989; 6:S219.

182. Awni WM, Luke DR, Opsahl JA, Halstenson CE, Matzke GR. Hepatic blood flow and oxidative metabolism in hemodialysis patients. 89th Annual Meeting of the American Society of Clinical Pharmacology and Therapeutics, 1988. Abstract published in Clin Pharmacol Ther 1988;43:147.

183. Awni WM, Heim-Duthoy KL, Rao KV, Kasiske BL. Pharmacokinetics of cyclosporine and its M1, M17 and M21 metabolites in renal transplant patients over time. 89th Annual Meeting of the American Society of Clinical Pharmacology and Therapeutics, 1988. Abstract published in Clin Pharmacol Ther 1988;43:198.

184. Matzke GR, Sanders K, Kovarik J, Awni WM. Predictive performance of Bayesian dosing of gentamicin: effect of population parameter estimates. 89th Annual Meeting of the American Society of Clinical Pharmacology and Therapeutics, 1988. Abstract published in Clin Pharmacol Ther 1988;43:164.

185. Grasela TH, Guay DR, Awni WM, Rybak MJ, Nahata MC, Reed MD, Matzke GR. Population pharmacokinetic parameters of vancomycin. 89th Annual Meeting of the American Society of Clinical Pharmacology and Therapeutics, 1988. Abstract published in Clin Pharmacol Ther 1988;43:132.


186. Guay DRP, Awni WM, Fant B, Kenny M, Matzke GR. Pharmacokinetics of teicoplanin in continuous ambulatory peritoneal dialysis patients. 28th Annual ICAAC Meeting, 1988.

187. Awni WM, Kovarik JM, Rachael KM, Matzke GR. Interaction of antipyrine and acetaminophen in normal volunteers. Annual Meeting of the American Association of Pharmaceutical Scientists, 1988. Abstract published in Pharm Res 1988;5(Suppl):174.

188. Matzke Gr, Najib J, Awni WM. Optimization of predictive performance of Bayesian dosing of gentamicin. Annual Meeting of the American Association of Pharmaceutical Scientists, 1988. Abstract published in Pharm Res 1988;5(Suppl):223.

189. Venkataram S, Awni WM, Jordan KR, Rahman YE. Pharmacokinetics of liposomal cyclosporin-A in rabbits: preliminary studies. Annual Meeting of the American Association of Pharmaceutical Scientists, 1988. Abstract published in Pharm Res 1988;5(Suppl):67

190. Schedewie HK, Lee LA, Bynce RP, Kudsk KA, Awni WM, Heerdt ME. Hepato-splanchnic alfentanil extraction and urinary/biliary/gastric excretion in swine. Annual Meeting of the International Anesthesia Research Society (IARS), 1988.

191. Luke DR, Kasiske BL, Matzke GR, Awni WM, Keane WF. Liposome delivery of cyclosporine prevents acute renal hemodynamic changes. Annual Meeting of the American Society of Nephrology, 1987. Abstract published in Kidney Int 1987;31:462.

192. Awni WM, Halstenson CE, Abraham PA, Yeh J, Reitberg D, Love S, Matzke GR. Pharmacokinetics of cetirizine in patients with various degrees of renal function. Annual Meeting of the American Association of Pharmaceutical Scientists, 1987. Abstract published in Pharm Res 1987;4:81S.

193. Halstenson CE, Matzke GR, Abraham PA, Opsahl JA, Awni WM, Elmquist WF, Keane WF. Single and multiple dose pharmacokinetics of enalapril in hypertensive patients with renal insufficiency. 88th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics, 1987. Abstract published in Clin Pharmacol Ther 1987;41:223.

194. Guay DRP, Matzke GR, Findlay JWA, Halstenson CE, Awni WM, Opsahl JA, Abraham PA. Codeine pharmacokinetics and pharmacodynamics in hemodialysis patients. 88th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics, 1987. Abstract published in Clin Pharmacol Ther 1987;41:222.

195. Nayak RK, Halstenson CE, Opsahl JA, Minn FL, Awni WM, Matzke GR. Pharmacokinetics of bepridil in hemodialysis patients. 88th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics, 1987. Abstract published in Clin Pharmacol Ther 1987;41:238.

196. Guay DRP, Matzke GR, Findlay JWA, Halstenson CE, Awni WM, Opsahl JA, Abraham PA. Codeine pharmacokinetics in hemodialysis patients. 16th Annual Meeting of the National Kidney Foundation, 1986.

197. Matzke GR, Awni WM, Skaar DJ, Sirgo MA, Plachetka JR. Interindividual and intraindividual variability of labetalol pharmacokinetics at steady state. III World Conference on Clinical Pharmacology and Therapeutics, 1986. Abstract published in Acta Pharmacologica et Toxicologica 1986;SV.


198. O'Connell ME, Matzke GR, Awni WM, et al. Bioavailability and disposition of metoclopramide following acute and chronic administration in patients with diabetic gastroparesis. Midwest Section, American Federation of Clinical Research, 1986. Abstract published in Clin Res 1986;34:907A.

199. Awni WM, Sawchuk RJ. Differential absorption of cyclosporine from two consecutive anatomic regions of the small intestine using an in situ perfusion model. 39th National Meeting of the APhA Academy of Pharmaceutical Sciences, 1985.

200. Awni WM, Sawchuk RJ. Pharmacokinetics of cyclosporine in rabbits. 15th Annual Graduate Student Pharmaceutics Research Meeting, 1983.

201. Awni WM, Sawchuk RJ. Preliminary pharmacokinetic studies of cyclosporine A in animals. 14th Annual Graduate Student Pharmaceutics Research Meeting, 1982.

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