ADVISORY COMMITTEE FOR PHARMACEUTICAL SCIENCE

November 16, 2000

University of Maryland, Shady Grove Campus
9640 Gudelsky Drive
Rockville, MD

Backgrounder Contents

Agenda pdf doc

Attendees

Committee Membership pdf doc

Invited Guests and Speakers pdf doc

Federal Register Notice – November 16, 2000 Subcommittee Meeting pdf   htm

Guidances

Guidance for Industry: Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System (August 2000)

Federal Register notice announcing availability of: Guidance for Industry: Bioavailability and Bioequivalence Studies for Orally Administered Drug Products –General Considerations (October 2000), October 27, 2000 htm

Guidance for Industry: Bioavailability and Bioequivalence Studies for Orally
Administered Drug Products –General Considerations (October 2000)

Draft Guidance for Industry: Average, Population, and Individual Approaches to Establishing Bioequivalence (August 1999)

Clinical Pharmacology Modeling and Simulation  pdf  doc