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AAPS workshop to explore regulatory approaches to bioavailability, bioequivalence

The American Association of Pharmaceutical Scientists (AAPS) will present the AAPS Workshop on Biopharmaceutics in the New Millennium: Regulatory Approaches to Bioavailability (BA) and Bioequivalence (BE), September 11-13, 2000 at the Omni Shoreham Hotel in Washington, DC. The meeting is co-sponsored by FDA, the International Pharmaceutical Federation (FIP) and the U.S. Pharmacopeial Convention, Inc. (USP).

Workshop attendees will:

Discuss new and emerging scientific technical approaches to measure BA and document BE for orally administered immediate release drug products.

Identify and explore drug development and scientific issues for orally administered extended release drug products.

Review and discuss clinical and other scientific issues and future directions for BA and BE studies.

Identify challenges and propose approaches for harmonization of international and regional regulatory guidances.

Session topics include: Metabolite Measurement When Is It Important? What Should Be the Criteria?; Optimizing the Performance of a New Extended Release Drug Product; and Steps Toward Regulatory Harmonization.


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Contact: Debbie Werfel
werfel@aaps.org
703-248-4743
American Association of Pharmaceutical Scientists
30-Jul-2000


Page: 1

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