Food and Drug Administration

Pharmaceutical Science Advisory Committee

Process Analysis Technology Subcommittee

March 12, 2003


Closing Report, Tom Layloff, FDA (HTM) (PPT)

Goals of the Advisory Subcommittee, Dr. Jurgen Venitz, MD, PhD (PDF)

Pharmacology-Toxicology Subcommittee, Dr. Robert Osterberg, PhD (HTM) (PPT)

Topical Dosage Forms Classification/Nomenclature, Dr. Yuan-yuan Chiu, PhD, FDA (HTM) (PPT)

Topical Dermatologic Dosage Forms and Vehicle Properties: Issues and Opportunities, Dr. Jonathan Wilkin, MD, FDA (HTM) (PPT)

Topical Drug Nomenclature, Dr. Lucinda Buhse, PhD, FDA (HTM) (PPT)

Proposed Definitions and Decision Tree for Topical Dosage Forms, Dr. Chi-wan Chen, PhD, FDA (HTM) (PPT)

USP Topical Dosage Forms Nomenclature, Dr. Herbert Carlin, DSc, USP (HTM) (PPT)

Topical Dosage Forms Classification/Nomenclature Questions, Yuan-yuan Chiu, PhD, FDA (HTM) (PPT)

Generic Topical Dermatologic Drug Products: Issues and Opportunities, Dr. Jonathan Wilkin, MD, FDA (HTM) (PPT)

Clinical Endpoint Bioequivalence Studies for Locally Acting Drugs, Dr. Dena Hixon, MD, FDA (HTM) (PPT)

Bioequivalence of Topical Drug Products, Dr. Dale Conner, PharmD, FDA (HTM) (PPT)

Comparability Protocols - Overview, Nancy Sager, FDA (HTM) (PPT)

Specifics on the Use of Comparability Protocols, Dr. Stephen Moore, PhD, FDA (HTM) (PPT)

Open Public Hearing

Bioequivalence of Topical Drugs: Use of the Cadaver Skin Model, Dr. Thomas Franz, MD, Dermtech Int'l (HTM) (PPT)