Drug Discovery & Clinical Evaluation of New Drugs
-
Upload
keerthi-sagar -
Category
Documents
-
view
153 -
download
3
Transcript of Drug Discovery & Clinical Evaluation of New Drugs
Drug Discovery & Clinical Evaluation of New Drugs
Dr. Keerthi Sagar J
Random ScreeningSerendipityMolecular
modificationRational drug
designingDesigning of a
Prodrug
Blind hitting procedure
Studies on animal behavior etc.
Eg: Morphine, Atropine, Digitalis, Penicillin
Limitations: Cumbersome , Time consuming, Expensive, Might not have fruitful results
Methods of Drug Development
Random ScreeningSerendipityMolecular
modificationRational drug
designingDesigning of a
Prodrug
Happy observation by chance
New use of old drugSide effects find a
new therapeutic useEg: Lignocaine,
Phenytoin, Methotrexate, Cyclophosphamide, Minodoxil
Methods of Drug Development
Random ScreeningSerendipityMolecular
modificationRational drug
designingDesigning of a
Prodrug
Synthesis of chemical analogues of drugs
Advantage in pharmacokinetic parameters
Decrease toxicityEg: ThaizidesLimitations: Me too
Drugs
Methods of Drug Development
Random ScreeningSerendipityMolecular
modificationRational drug
designingDesigning of a
Prodrug
Understanding biological activity and chemical structure
Eg: ACE inhibitors, H2 Antagonists
Methods of Drug Development
Random ScreeningSerendipityMolecular
modificationRational drug
designingDesigning of a
Prodrug
Eg: Levodopa, Paracetamol, N- acetyl Procainamide
Methods of Drug Development
From Hits To Leads
Sochlet Apparatus
Analysis of Active IngredientGas ChromatographyUV SpectrophotometerHPLCHPTLCNMR SpectrophotometerX- Ray Crystallography
Invitro methods Bioassay
Direct end point assayQuantal assay Graded assay
a. Bracketing assayb. Matching assayc. Interpolation assayd. Multiple point assay
In vivo studiesAnimal studies for behavior
Eddy’s Hot PlateElevated plus mazeRota rod apparatusElectroconvulsiometer
Toxicity studiesAcute toxicitySubacute toxicityChronic toxicitySpecial toxicity
Male fertility studiesFemale fertility studiesTeratogenicityCarcinogenicity
Clinical trialsSchedule Y – Drugs & Cosmetics Rules 2005
[Ministry of Health & Family Welfare]Definition : A systematic study of a new drug
in human subjects to generate data for discovering and verifying the clinical, pharmacological & adverse effects with the objective of determining safety and efficacy of new drugs
Need for clinical trialsEvaluation of new drugs for its efficacy &
safetyTo know benefits and risks
Types of Clinical trialsTherapeutic trials
Analgesics, anticonvulsantsPrevention trials
Vitamins, VaccinesDiagnostic trials
Finding better testScreening trials
MRI, PET ScanQuality of life trials
Side effects reducing drugs
Requirements for Clinical TrialsPreclinical study dataClearance from IRB/ IECInformed ConsentApproval from Regulatory authorities like
FDA, IND
Informed consentOral consentWritten consent
Institutional Ethics Committee