On

Wednesday, January 30, 2002 at 7:30PM

at

The Palace of Asia, Ft. Washington, PA

Directions to
The Palace of Asia

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_________________________________________________________

Will be Pleased to Present:

Lewis Klunk, Ph.D.

 

Executive Director, Biotransformation, Bristol-Myers Squibb

 

Who will speak on

Metabolites in Safety Testing (MIST)

There has been increasing attention from the pharmaceutical industry and regulatory agencies to the role of metabolites as pharmacologically active molecules and potential mediators of toxicity. In 1999 the Pharmaceutical Research and Manufacturers of America (PhRMA) commissioned the Metabolites in Safety Testing (MIST) committee comprising members of the Drug Metabolism, Clinical Pharmacology, and Safety Assessment PhRMA subcommittees to address this topic; the findings were presented and discussed further at a workshop held with PhRMA member companies and the FDA in November, 2000. Examples of issues discussed were the timing of metabolite studies, the definition of a major metabolite, the appropriateness of determining metabolite pharmacokinetics, species specific or unique metabolites, and the determination of enzymes responsible for major metabolic pathways. While in some areas there was no clear industry consensus on how best to approach certain issues, a list of points to consider was developed which can form the basis of continued dialog among the pharmaceutical industry and regulatory agencies. The deliberations of the MIST committee and discussions from the workshop have been summarized in a PhRMA position paper, which will be published early in 2002. This talk will highlight the major areas of discussion and points to consider on metabolites in safety testing and drug development.

 

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• Payment can be made by January 25, 2002.
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RESERVATIONS 
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• With your steering committee member.
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  228 Maugers Mill Rd., Pottstown, PA 19464
• Or register on our Web Site at www.dvdmdg.org/dmdgreg.htm

Directions to
The Palace of Asia

Register for an Event Here!!