ADVISORY COMMITTEE FOR PHARMACEUTICAL SCIENCE
CDER Advisory Committee Conference Room
5630 Fishers Lane
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
10:15 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