Food and Drug Administration

Advisory Committee for Pharmaceutical Science

November 29, 2001

Slides

Dermatopharmacokinetics (DPK), Dale P Conner, PharmD, FDA  [ppt]  [htm]

Bioequivalence Assessment of three 0.025% tretinoin gel products: Dermatopharmacokinentic vs. Clinical Trial Methods, Lynn K Pershing PhD, University of Utah  [ppt]  [htm]

Study #1, Avita Gel 0.025% vs Retin-A Gel 0.025%, Franz  [pdf]  [htm]  [Word]

Internal DPK Study, Mamata S Gokhale, PhD, FDA   [ppt]  [htm]

Differences in DPK Methods, Dale P Conner, PharmD, FDA   [ppt]  [htm]

Individual Bioequivalence, Lawrence J Lesko PhD, FDA  [ppt]  [htm]

Individual Bioquivalence: Background and Concepts, Mei-Ling Chen PhD, FDA   [ppt] [htm]

Results from Replicate Design Studies in ANDAs, Rabi Patnaik PhD, FDA   [ppt]  [htm]

Individual Bioequivalence:  Have the Opinions of the Scientific Community Changed? Leslie Z Benet PhD, University of California   [ppt]  [htm]

Bioequivalence Criteria Research Plan, Stella G Machado PhD, FDA   [ppt]  [htm]

OPEN PUBLIC HEARING

FDA Comments on Skin Stripping Results, K L Spear MD, Spear Pharmaceuticals   [ppt]  [htm]

System Absorption as the Most Accurate and Sensitive Method of Determining Bioequivalence of Generic Topical Products, Chris Hendy PhD, Novum Pharmaceutical Research Services   [ppt]  [htm]

A Derivation of the Distribution of the Individual Bioequivalence Metric, M Mohan Sondhi   [pdf]

Some Features, Issues, and Problems of Individual Bioequivalence, Laszlo Endrenyl and Laszio Tothfalusi, University of Toronto  [ppt]  [htm]

IBE Criteria Flaw, Development of the Criterion, Charles Bon  [ppt] [htm]

Individual Bioequivalence:  Strengths and Weaknesses of the Current Approach:  View From the Generic Pharmaceutical Association by MDS Pharma Services, Mario Tanguay BPharm PhD, Pharmacokinetics  [ppt]  [htm]

BE Issues of HVD & HVDP, Kamal K Midha, Maureen Rawson, Gordon McKay, John W Hubbard, PharmaLytics Inc  [ppt]  [htm]