CDER Advisory Committee Conference Room

5630 Fishers Lane

Rockville, MD


Friday, July 20, 2001

8:30 Call to Order/ Steve R. Byrn, Ph.D.

Conflict of Interest Nancy Chamberlin, Pharm.D, Exec. Sec.

8:35 Clinical Pharmacology

8:35 Introduction and Background Larry Lesko, Ph.D.

8:45 Overview of draft Lactation Studies Guidance Arzu Selen, Ph.D.

8:55 Nonclinical and clinical methods to determine the amount Shinya Ito, M.D.

of drug in breast milk

Drug Transfer into Milk: Clinical Methods and Issues Patrick J. McNamara, Ph.D.

9:25 Committee and Panel Discussion

Issue: Methods to determine drug transfer into breast milk

and interpretation of data

10:00 Break

10:15 Open Public Hearing

11:15 Complex Drug Substances - Liposome Drug Products

11:15 Introduction Mei-Ling Chen, Ph.D.

11:20 Overview of Liposome Drug Products Francis J. Martin, Ph.D.

11:45 Pharmaceutical Equivalence: CMC Issues Arthur Shaw, Ph.D.

12:00 Bioavailability and Bioequivalence:

Biopharmaceutics Issues Kofi Kumi, Ph.D.

12:15 Committee Discussion

Topic #1 - PE issues

Topic #2 - BA/BE issues

12:45 Adjourn