Food and Drug Administration

Center for Drug Evaluation and Research

Advisory Committee for Pharmaceutical Science

October 21-22, 2003

Best Western Washington Gateway Hotel

1251 West Montgomery Avenue

Rockville, MD 20857

Agenda

Day 1: Tuesday, October 21, 2003

8:30 Call to Order and Opening Remarks Art Kibbe, Ph.D.

Chair, ACPS

Introduction of Committee

Conflict of Interest Statement Hilda F. Scharen, M.S.

Executive Secretary, ACPS

8:45 Introduction Helen Winkle

Director, Office of Pharmaceutical Science, CDER, FDA

Subcommittee Reports

9:00 Manufacturing Judy Boehlert, Ph.D.

Chair, Manufacturing Subcommittee

Clinical Pharmacology Jürgen Venitz, M.D., Ph.D.

Chair, Clinical Pharmacology Subcommittee

Draft PAT Guidance

10:00 Update Ajaz Hussain, Ph.D.

Deputy Director, Office of Pharmaceutical Science, CDER, FDA

Questions/Discussion

10:30 Break

Parametric Tolerance Interval Test for Dose Content Uniformity

10:45 Overview and Issues Ajaz Hussain, Ph.D.

Deputy Director, Office of Pharmaceutical Science, CDER, FDA

11:30 Open Public Hearing

12:30 Lunch

1:30 Approaches for resolving identified issues

IPAC-RS Presentations

2:30 Break

2:45 Committee Discussion and Recommendations

4:30 Adjourn

Food and Drug Administration

Center for Drug Evaluation and Research

Advisory Committee for Pharmaceutical Science

October 21-22, 2003

Best Western Washington Gateway Hotel

1251 West Montgomery Avenue

Rockville, MD 20857

Agenda

Day 2: Wednesday, October 22, 2003

8:30 Call to Order and Opening Remarks Art Kibbe, Ph.D.

Chair, ACPS

Introduction of Committee

Conflict of Interest Statement Hilda F. Scharen, M.S.

Executive Secretary, ACPS

Risk-based CMC Review Proposals

8:45 Current Thinking

Focus on “process understanding” Ajaz Hussain, Ph.D.

Deputy Director, Office of Pharmaceutical Science, CDER, FDA

Issues and challenges

Committee Discussion

10:15 Break

Nomenclature

10:45 Proposals for resolving issues and challenges

FDA Perspective

Committee Discussion

12:00 Lunch

1:00 Open Public Hearing

Food and Drug Administration

Center for Drug Evaluation and Research

Advisory Committee for Pharmaceutical Science

October 21-22, 2003

Best Western Washington Gateway Hotel

1251 West Montgomery Avenue

Rockville, MD 20857

Agenda

Day 2: Wednesday, October 22, 2003 (Cont’d)

Research Plan for Generics – Bioequivalence of Topical Products

2:00 Generic Drug Research Pogram

Dermatopharmacokinetics: Improvement of

methodology for assessing bioequivalence of

topical products

Bioequivalence of topical products: FDA Perspective

3:00 Break

3:15 Committee Discussion

4:45 Conclusion and Summary Remarks Ajaz Hussain, Ph.D.

Deputy Director, Office of Pharmaceutical Science, CDER, FDA

5:00 Adjourn