| Summary: Webinar with speakers from Xceleron, Constella and GSK. |
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| Presentation Date: | 11 Apr 2008 |
| Presentation Type: | Webinar |
| Recording Link: | Click here to listen to the webinar |
Mr. Gilbert Carnathan: Principal Drug Development Consultant, Constella group
FDA and Drug Development
Presents the effect the US FDA Guidance document will have on the drug development process.
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Mr. Graeme Young: Manager DMPK, GSK
GSK’s use of AMS for metabolism data
GSK’s use of AMS technology to obtain earlier human metabolism data.
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Dr. Graham Lappin: Head of Research and Development, Xceleron,
Xceleron’s META-ID
Xceleron’s META-ID: The cost effective way to follow the FDA Guidance.
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Xceleron’s META-ID™ allows drug development companies to obtain critical human metabolism information earlier in the drug development process.
The US FDA Guidance to Industry ‘Safety Testing of Drug Metabolites’ calls for drug developers to investigate human specific metabolism earlier in the development process and advises that any metabolite constituting 10% or more of parent AUC be tested for toxicity.
Xceleron is joined by speakers from Constella and GSK to clarify what this guidance means to drug developers and what measures can be taken to ensure that late stage surprises are avoided.
Microdosing studies: a consideration on analytical technology choice
"...AMS [is] an invaluable tool in our early drug development program, allowing us to quickly assess bioavailability in humans and focus resources on our most promising drug candidates going forward."
Find out how we can help you accelerate your drug-development program.