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Pharmapendium is the only online resource for searching all drug approval review and correspondence documentation since 1938 (FDA/CDER/FOI archived FDA/ EMA EPAR approval document database), giving you unrivalled insights into the entire history of drug development and comparative data in preclinical, clinical and post-marketing phases.In this webinar we:- Showed you how your peers are using Pharmapendium to successfully move drugs along the pipeline.- Demonstrated how you can be “Better informed” and what this really means to you and your colleagues.
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Welcome to our PharmaPendium Webinar!
PharmaPendium, for informed drug development decisions – An introduction
Your host: Chris Flemming Your presenter: Phil MacLaughlin
About us
Webinar control panel:
‘chat’ or ‘ask a question’ for questions
and comments
Option for full screen view
Q&A after presentation
Need to know
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What is PharmaPendium?Key product points: Unique content
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
Other key sources: •EMA, •AERS (post-marketing events)
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What is PharmaPendium?Extracted Data
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)
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FDA Approval Packages:Examples of original documents
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OCR Example
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FDA Approval PackageSearch result
Pharmacokinetic Module
Project Title
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.
PK Module content sources
Project Title
Over 1,000,00 Extracted parameter values from (Every 2 mos.):• FDA Reviews from 1938-Present (FDA Approval Packages)• EMEA EPARs from ~ 1995 – Present
• With filterable fields and special designations for:• Drug name, Species, Study Group (population), Dose,
Route, Parameter, Value (normalized in searching), SD• Enantiomers, Metabolites, Tissue-specific studies,
Concomitants (Food Effects)
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Let’s take a look at PharmaPendium
….by going to www.pharmapendium.com
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POLL
The poll should appear on your screen shortly….
Questions & Answers
Q&A will be sent to you by email.
For more information and questions please contact [email protected]
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.