ADVISORY COMMITTEE FOR PHARMACEUTICAL SCIENCE

July 20, 2001

Slides

Clinical Pharmacology

Drug Transfer Into Breast Milk and Interpretation of Data, Introduction and Background, Lawrence J Lesko, FDA   ppt   htm

Drug Transfer into Breast Milk: Nonclinical and Clinical Methods, Overview of draft Lactation Studies Guidance, Arzu Selen PhD   ppt   htm

Assessing Drug Transfer into Breast Milk, Shinya Ito MD, Hospital for Sick Children  ppt   htm

Drug Transfer into Milk: Clinical Methods & Issues, Patrick J McNamara, University of Kentucky   ppt   htm

  Open Public Hearing

Liposomal Drug Products: The Importance of Supramolecular Structure, Christine E Swensen, Elan   ppt   htm

Liposomal Therapeutics: Process vs. Formulation, Gerard M Jensen PhD, Gilead Sciences Inc   ppt   htm

Complex Drug Substances - Liposome Drug Products

Introduction, Mei-Ling Chen PhD   ppt   htm

Liposome Drug Products: Product Evolution and Influence of Formulation on Pharmaceutical Properties and Pharmacology, Frank Martin, J&J ALZA   ppt   htm

Liposome Drug Products: Chemistry Manufacturing and Control Issues, Arthur B Shaw PhD, FDA   ppt    htm

Bioavailability and Bioequivalence: Biopharmaceutics Issues,  Kofi Kumi PhD   ppt  htm