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PharmaPendium - An Introduction.25april2012
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Transcript of PharmaPendium - An Introduction.25april2012
![Page 1: PharmaPendium - An Introduction.25april2012](https://reader036.fdocuments.in/reader036/viewer/2022062706/55796e38d8b42a3a5c8b4f04/html5/thumbnails/1.jpg)
Welcome to our PharmaPendium Webinar!
PharmaPendium, for informed drug development decisions
Your host: Ann-Marie Roche Your presenter: Pooja Jain
An introduction
![Page 2: PharmaPendium - An Introduction.25april2012](https://reader036.fdocuments.in/reader036/viewer/2022062706/55796e38d8b42a3a5c8b4f04/html5/thumbnails/2.jpg)
Welcome to our PharmaPendium Webinar!
PharmaPendium, for informed drug development decisions
Your host: Ann-Marie Roche Your presenter: Pooja Jain
An introduction
![Page 3: PharmaPendium - An Introduction.25april2012](https://reader036.fdocuments.in/reader036/viewer/2022062706/55796e38d8b42a3a5c8b4f04/html5/thumbnails/3.jpg)
About us
![Page 4: PharmaPendium - An Introduction.25april2012](https://reader036.fdocuments.in/reader036/viewer/2022062706/55796e38d8b42a3a5c8b4f04/html5/thumbnails/4.jpg)
Webinar control panel:
‘chat’ or ‘ask a question’ for questions
and comments
Option for full screen view
Q&A after presentation
Need to know
![Page 5: PharmaPendium - An Introduction.25april2012](https://reader036.fdocuments.in/reader036/viewer/2022062706/55796e38d8b42a3a5c8b4f04/html5/thumbnails/5.jpg)
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Today’s Agenda
What is PharmaPendium?
How do the documents appear in PharmaPendium?
What is the Pharmacokinetic Module?
Poll
Live Demo
Q&A
![Page 6: PharmaPendium - An Introduction.25april2012](https://reader036.fdocuments.in/reader036/viewer/2022062706/55796e38d8b42a3a5c8b4f04/html5/thumbnails/6.jpg)
What is PharmaPendium?
![Page 7: PharmaPendium - An Introduction.25april2012](https://reader036.fdocuments.in/reader036/viewer/2022062706/55796e38d8b42a3a5c8b4f04/html5/thumbnails/7.jpg)
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What is PharmaPendium?
First product to offer both searchable FDA approval packages and EMA EPARs
• 1.9M newly-searchable pages covering all of FDA history, over 70 years (from 1938),
• Searchable EMA EPAR content (from 1995)
![Page 8: PharmaPendium - An Introduction.25april2012](https://reader036.fdocuments.in/reader036/viewer/2022062706/55796e38d8b42a3a5c8b4f04/html5/thumbnails/8.jpg)
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What is PharmaPendium?
First product to offer both searchable FDA approval packages and EMA EPARs
• 1.9M newly-searchable pages covering all of FDA history, over 70 years (from 1938),
• Searchable EMA EPAR content (from 1995)
Used primarily for Preclinical assessment (Safety, PK, Efficacy) and Regulatory Affairs
![Page 9: PharmaPendium - An Introduction.25april2012](https://reader036.fdocuments.in/reader036/viewer/2022062706/55796e38d8b42a3a5c8b4f04/html5/thumbnails/9.jpg)
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What is PharmaPendium?
First product to offer both searchable FDA approval packages and EMA EPARs
• 1.9M newly-searchable pages covering all of FDA history, over 70 years (from 1938),
• Searchable EMA EPAR content (from 1995)
Used primarily for Preclinical assessment (Safety, PK, Efficacy) and Regulatory Affairs
AERS (post-marketing events)
![Page 10: PharmaPendium - An Introduction.25april2012](https://reader036.fdocuments.in/reader036/viewer/2022062706/55796e38d8b42a3a5c8b4f04/html5/thumbnails/10.jpg)
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What is PharmaPendium?
First product to offer both searchable FDA approval packages and EMA EPARs
• 1.9M newly-searchable pages covering all of FDA history, over 70 years (from 1938),
• Searchable EMA EPAR content (from 1995)
Used primarily for Preclinical assessment (Safety, PK, Efficacy) and Regulatory Affairs
AERS (post-marketing events)
Unique Content
![Page 11: PharmaPendium - An Introduction.25april2012](https://reader036.fdocuments.in/reader036/viewer/2022062706/55796e38d8b42a3a5c8b4f04/html5/thumbnails/11.jpg)
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What is PharmaPendium?
First product to bring together preclinical, clinical & post marketing data
•Normalized terminology on searches, extracted data•Which experimental data translates, why or why not?
![Page 12: PharmaPendium - An Introduction.25april2012](https://reader036.fdocuments.in/reader036/viewer/2022062706/55796e38d8b42a3a5c8b4f04/html5/thumbnails/12.jpg)
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What is PharmaPendium?
First product to bring together preclinical, clinical & post marketing data
•Normalized terminology on searches, extracted data•Which experimental data translates, why or why not?
Over 1,100,000 extracted drug safety observations•Normalized AE/Tox terminology mapped to Class, Target, Structural Chemistry
![Page 13: PharmaPendium - An Introduction.25april2012](https://reader036.fdocuments.in/reader036/viewer/2022062706/55796e38d8b42a3a5c8b4f04/html5/thumbnails/13.jpg)
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What is PharmaPendium?
First product to bring together preclinical, clinical & post marketing data
•Normalized terminology on searches, extracted data•Which experimental data translates, why or why not?
Over 1,100,000 extracted drug safety observations•Normalized AE/Tox terminology mapped to Class, Target, Structural Chemistry
Over 1,300,000 extracted PK parameter data, preclinical and clinical. Normalized and related the same way (structure, class, target)
![Page 14: PharmaPendium - An Introduction.25april2012](https://reader036.fdocuments.in/reader036/viewer/2022062706/55796e38d8b42a3a5c8b4f04/html5/thumbnails/14.jpg)
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What is PharmaPendium?
First product to bring together preclinical, clinical & post marketing data
•Normalized terminology on searches, extracted data•Which experimental data translates, why or why not?
Over 1,100,000 extracted drug safety observations•Normalized AE/Tox terminology mapped to Class, Target, Structural Chemistry
Over 1,300,000 extracted PK parameter data, preclinical and clinical. Normalized and related the same way (structure, class, target)
Extracted Data
![Page 15: PharmaPendium - An Introduction.25april2012](https://reader036.fdocuments.in/reader036/viewer/2022062706/55796e38d8b42a3a5c8b4f04/html5/thumbnails/15.jpg)
How do the documents appear in PharmaPendium?
![Page 16: PharmaPendium - An Introduction.25april2012](https://reader036.fdocuments.in/reader036/viewer/2022062706/55796e38d8b42a3a5c8b4f04/html5/thumbnails/16.jpg)
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FDA Approval Packages:Examples of original documents
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FDA Approval PackageSearch result
![Page 18: PharmaPendium - An Introduction.25april2012](https://reader036.fdocuments.in/reader036/viewer/2022062706/55796e38d8b42a3a5c8b4f04/html5/thumbnails/18.jpg)
What is the Pharmacokinetic Module?
![Page 19: PharmaPendium - An Introduction.25april2012](https://reader036.fdocuments.in/reader036/viewer/2022062706/55796e38d8b42a3a5c8b4f04/html5/thumbnails/19.jpg)
Pharmacokinetic Module
Unprecedented access to Preclinical and Clinical exposure data extracted from FDA packages (current & historic) and EMEA documents.
![Page 20: PharmaPendium - An Introduction.25april2012](https://reader036.fdocuments.in/reader036/viewer/2022062706/55796e38d8b42a3a5c8b4f04/html5/thumbnails/20.jpg)
Pharmacokinetic Module
Unprecedented access to Preclinical and Clinical exposure data extracted from FDA packages (current & historic) and EMEA documents.
• preclinical and clinical exposure data at multiple parameters and usually under various experimental conditions:
![Page 21: PharmaPendium - An Introduction.25april2012](https://reader036.fdocuments.in/reader036/viewer/2022062706/55796e38d8b42a3a5c8b4f04/html5/thumbnails/21.jpg)
Pharmacokinetic Module
Unprecedented access to Preclinical and Clinical exposure data extracted from FDA packages (current & historic) and EMEA documents.
• preclinical and clinical exposure data at multiple parameters and usually under various experimental conditions:
• Concomitant drugs, disease states, demographic differences, etc.
![Page 22: PharmaPendium - An Introduction.25april2012](https://reader036.fdocuments.in/reader036/viewer/2022062706/55796e38d8b42a3a5c8b4f04/html5/thumbnails/22.jpg)
Pharmacokinetic Module
Unprecedented access to Preclinical and Clinical exposure data extracted from FDA packages (current & historic) and EMEA documents.
• preclinical and clinical exposure data at multiple parameters and usually under various experimental conditions:
• Concomitant drugs, disease states, demographic differences, etc.
• The level of PK data to be contained in this database is almost never published (competitive reasons) at this level of detail.
![Page 23: PharmaPendium - An Introduction.25april2012](https://reader036.fdocuments.in/reader036/viewer/2022062706/55796e38d8b42a3a5c8b4f04/html5/thumbnails/23.jpg)
Pharmacokinetic Module
Unprecedented access to Preclinical and Clinical exposure data extracted from FDA packages (current & historic) and EMEA documents.
• preclinical and clinical exposure data at multiple parameters and usually under various experimental conditions:
• Concomitant drugs, disease states, demographic differences, etc.
• The level of PK data to be contained in this database is almost never published (competitive reasons) at this level of detail.
Pharmacokinetics, preclinical and clinical, & Drug Safety databases browsable within the same platform.
![Page 24: PharmaPendium - An Introduction.25april2012](https://reader036.fdocuments.in/reader036/viewer/2022062706/55796e38d8b42a3a5c8b4f04/html5/thumbnails/24.jpg)
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POLL
The poll should appear on your screen shortly….
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Let’s take a look at PharmaPendium
….by going to www.pharmapendium.com
![Page 26: PharmaPendium - An Introduction.25april2012](https://reader036.fdocuments.in/reader036/viewer/2022062706/55796e38d8b42a3a5c8b4f04/html5/thumbnails/26.jpg)
Questions & Answers
![Page 27: PharmaPendium - An Introduction.25april2012](https://reader036.fdocuments.in/reader036/viewer/2022062706/55796e38d8b42a3a5c8b4f04/html5/thumbnails/27.jpg)
Q&A will be sent to you by e-mail.
For more information and questions please contact [email protected]
The next PharmaPendium webinar will on the 29th of May and will focus on Pharmacokinetics.
Go to www.trainingdesk.elsevier.com/pharmapendium for all training related materials.
Please fill out the survey that appears on your screen after
leaving the webinar.
Please fill out the survey that appears on your screen after
leaving the webinar.