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Patricia_1

12/27/03 12:56 PM

#94 RE: Patricia_1 #93

Pfizer/Xenotech Conference June 14-16, 2004

The Institute for Scientific Exchange, Inc. Presents:

DDI-2004

7th International Conference on Drug-Drug Interactions:

Mechanism, Prediction, Accuracy, Clinical Approaches and Novel DDI Events

June 14-16, 2004

San Diego, CA, USA

Conference Venue: San Diego Marriott Hotel & Marina
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Tuesday, June 15, 2004

Pfizer + Xenotech:

10:30 AM – 11:15 AM

Immortalized and Fresh Human Hepatocytes: Use and Performance in Metabolism, Induction and Toxicity Screening (Andrew Parkinson, XenoTech, Lenexa, KS) Human hepatocytes play several key roles in preclinical drug development, including assessment of enzyme induction, cellular toxicity, drug metabolism and species comparisons. This presentation compares fresh and cryopreserved human hepatocytes to a new human hepatocyte cell line that has the potential to solve the problem of supply and variability that restrict the use of human hepatocytes for enzyme induction and other in vitro screening.

11:15 AM – 12:00 PM

Predicting Clinical DDI Arising from CYP3A4 Induction Using In Vitro Data: Studies with the Fa2N-4 Immortalized Hepatocyte Line (Sharon L. Ripp, Pfizer Global Research & Development; Groton, CT) The Fa2N-4 human hepatocyte line, when treated with prototypical inducers, shows a robust induction of CYP3A4 mRNA and enzymatic activity. We are examining ways to use this in vitro induction data to predict clinical DDI due to CYP3A4. One possibility is to combine potency and efficacy data from Fa2N-4 cells with efficacious plasma concentrations to assess in vivo induction potential. Studies assessing the validity of this approach using prototypical inducers will be discussed.



http://www.isciencex.com/DDI-2004%20program%20FINAL.htm