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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 $\quad$ Applied Session: Yes

Session Title: Assessment of the U.S. FDA Draft Guidance on Statistical Procedures for Bioequivalence Studies

Organizer: Liu, Jen-pei  

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

Chair: Liu, Jen-pei  

1. Population and Individual Bioequivalence: A View from the Pharmaceutical Science Advisory Committee $\quad$ Davidian, Marie  

2. Evaluation of Individual Bioequivalence: An Industry's Perspective $\quad$ Chow, Shein-Chung  

3. Uncertainty of Estimated Variances in the Determination of Individual Bioequivalence $\quad$ Endrenyi, Laszlo  

Discussant: Bolognese, James A.  

List of speakers who are nonmembers: 1

David Scott