Sponsor(s): Sponsoring Section/Society: ASA-BIOPHARM
Session Time: 10:30-12:20 Monday
Estimated Audience Size: 200-250
A/V Request: Two Overheads
Theme Session: Yes Applied Session: Yes
Session Title: Assessment of the U.S. FDA Draft Guidance on Statistical Procedures for Bioequivalence Studies
Session Timing: Opening Remarks by Chair - 5 minutes First Speaker - 25 minutes Second Speaker - 25 minutes Third Speaker - 25 minutes Discussant - 15 minutes Floor Discussion - 15 minutes
1. Population and Individual Bioequivalence: A View from the Pharmaceutical Science Advisory Committee Davidian, Marie
2. Evaluation of Individual Bioequivalence: An Industry's Perspective Chow, Shein-Chung
3. Uncertainty of Estimated Variances in the Determination of Individual Bioequivalence Endrenyi, Laszlo
Discussant: Bolognese, James A.
List of speakers who are nonmembers: 1