searching for pharmacokinetic data in pharmapendium
DESCRIPTION
During our 45 min Pharmapendium webinar, our Pharmapendium expert Pooja Jain, showed us you how the Pharmacokinetic module in Pharmapendium can do the following: - Make drug development project risk assessments - Identify competitive opportunities in a therapeutic area or drug class - Gain critical understanding to potential pharmacokinetic responses by looking at critical data such as food effects, concomitant drugs, co-morbidities and demographic effectsTRANSCRIPT
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Welcome to our PharmaPendium Webinar!
Your host: Ann-Marie Roche
Your presenter: Pooja Jain
Pharmacokinetics module
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About us
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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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Pharmacokinetics Module:Value
Unprecedented access to Preclinical and Clinical exposure data extracted from FDA packages (current & historic) and EMEA documents.
• ~2,000 drugs with 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.
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Pharmacokinetics Module:Content
Extracted parameter values for at least 2,000 drugs, taken from :
• FDA Reviews from 1938-Present (FDA Approval Packages)• If you do not have FDA Classic Collection, you will have acesss to
extracted data, and citation, but will not be able to drill-in to the original document.
• EMEA EPARs from ~1995 – Present
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Pharmacokinetics Module:Content
• Will contain an estimated 1.25 million lines of extracted pharmacokinetics observations
• 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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Pharmacokinetics Module:Sample Uses
Creating Modeling Sets: valuable data in modeling therapeutic window for new drugs
Drug Development Project assessments • A newly-available wealth of comparative data to aid in development
candidates’ decisions, prioritizations, and direction.
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Pharmacokinetics Module:Sample Uses
Competitive Opportunity:
• Can we deliver this drug better than our competitors?
• Where has the bar been set in this drug class?
• Where are the opportunities in Drug Class X using our proprietary methods / formulations?
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Let’s go to www.pharmapendium.com
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How may I find protein binding data for the same drug in animal and human studies?
Check notes for all solutions in PP
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Now let’s see what kind of data we can find if we look up for example, a drug called Aromasin, a prescription medicine for the treatment of breast cancer.
Check notes for all solutions in PP
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Now let’s look for protein binding differences for another drug, Rosuvastatin. Rosuvastatin is a member of the drug class statins and is used for lowering cholesterol. Now if we go under clinical data and select for bioavailability, I would like to show you what other types of insights you can get.
Check notes for all solutions in PP
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POLL
The poll should appear on your screen shortly….
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So if we want to see how we can find metabolite data using the PK module in PP, let’s click on the PK tab.
Check notes for all solutions in PP
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Now, if we want to see how we can find Cmax data using the PK module in PP, based on what you have seen already, we can probably not only look for Cmax data, but also ask questions like, is Cmax affected by fed vs fasted states? Will this in turn affect the bioavailability of the drug?
Check notes for all solutions in PP
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So now, if we want to find some interesting Tmax data, which is data pertaining to how long it takes to reach Cmax, we can for example look at analgesics. So we can go under drugs and drug classes. Click on analgesics and add it. Then under the PK parameters, we can click on Distribution, then time values, and then tmax. Then we click search now. And here you can see all the results.
Check notes for all solutions in PP
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Questions & Answers
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The Q&A will be sent to you by email.
For more information and questions please contact [email protected]
The next PharmaPendium webinar is an introductory webinar and will be on the 27th of June.
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.