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Metabolic and Transporter Drug Interactions: Design and Conduct of Preclinical and Clinical Studies*
Tuesday, November 13
7:00 am – 8:15 am
Sunrise Session
ACPE #073-999-07-574-L04
Understanding ADME characteristics of a new drug earlier in the drug development is important. Similarly, the drug-drug interaction potential of a new drug should be explored as a part of the assessment of safety and effectiveness. Presentations will include latest scientific consensus on timing, models and criteria for the conduct of in vitro metabolic- and transporter-based drug interaction studies. Implications of in vitro and in vivo drug interaction study findings on drug product labeling will also be discussed. Students are encouraged to a) visit the FDA’s public website on “Drug Development and Drug Interactions” http://www.fda.gov/cder/drug/drugInteractions/default.asp ; b) participate in a lively discussion to learn and to provide insights into use of in vitro methods for the prediction of in vivo drug interactions.
Moderator
Jeevan Kunta, Ph.D.
Bristol-Myers Squibb Company
Current Practice of Evaluating Metabolic and Transporter Based Clinical Drug-drug Interactions
Srikanth C. Nallani, Ph.D.
U.S. Food and Drug Administration
Transporter Phenotyping: Application of Novel Technologies in Drug Discovery & Development
Praveen Balimane, Ph.D.
Bristol-Myers Squibb Company
Preclinical Evaluation of Metabolic Drug Interactions
William G. Humphreys, Ph.D.
Bristol-Myers Squibb Company
*Session tentatively scheduled to be recorded.
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