Food and Drug Administration

Advisory Committee for Pharmaceutical Science

October 22, 2003


Risk Based CMC Review Current Thinking - Overview, Dr. Yuan-yuan, Chiu, PhD, FDA (HTM) (PPT)

Risk Based CMC Review, Dr. Vilayat Sayeed, PhD, FDA (HTM) (PPT)

An Example of Process Understanding Directed Risk Based CMC Regulatory Oversight of Post-Approval Change, Dr. Ajaz Hussain, PhD, FDA (HTM) (PPT)

Risk-Based CMC Review Proposals: Issues and Challenges, Dr. Moheb Nasr, PhD, FDA (HTM) (PPT)

Pharmaceutical Nomenclature Issues and Challenges, Dr. Moheb Nsar, PhD, FDA (HTM) (PPT)

Office of Generic Drugs Research Program, Dr. Lawrence Yu, PhD, FDA (HTM) (PPT)

Dermatopharmacokinetics: Improvement of Methodology for Assessing Bioequivalence of Topical Products, Annette Bunge, Colorado School of Mines and Richard Guy, Universites de Geneve et Lyon, France (PDF)

The Pursuit of Alternative Methodologies For Demonstrating Bioequivalence for Generic Topical Dermatologic Drug Products, Dr. Jonathan Wilkin, MD, FDA (HTM) (PPT)

Bioequivalence of Topical Products - Discussion Points, Dr. Lawrence Yu, PhD, Dr. Annette Bunge, PhD, Dr. Jonathan Wilkin, MD (HTM) (PPT)