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Leveraging Prior Quantitative Knowledge to Guide Drug Development Decisions and Regulatory Science Recommendations: Impact of FDA Pharmacometrics During 2004-2006

From Pharmacometrics, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland.

The End-of-Phase 2A meetings are proposed to identify opportunities to make innovative medical products available sooner and to increase the quality of drug applications through early meetings between sponsors and the FDA. This article summarizes the overall experience across 11 pilot End-of-Phase 2A meetings since 2004. Four case studies are presented in more detail to demonstrate the various issues and methods encountered at these meetings. Overall, industry and FDA scientists ranked these meetings to be "very helpful" (average score of 4 on a scale of 1 to 5). In almost all the instances the sponsors changed their drug development plans subsequent to these extensive quantitative analyses-based meetings. A draft Guidance is being developed to be issued in 2008, and we hope this initiative will be resourced by then.

Key Words: Regulatory decisions • EOP2A meeting • modeling • simulation • FDA • drug development • pharmacokinetics • pharmacodynamics • pharmacometrics

Address for correspondence: Yaning Wang, PhD, Team Leader, Pharmacometrics, Office of Clinical Pharmacology, Office of Translational Sciences, CDER, FDA, 10903 New Hampshire Avenue, Building 21, Room 3662, Silver Spring, MD 20993-0002; e-mail: yaning.wang{at}fda.hhs.gov.

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