Food and Drug Administration DRAFT

Center for Drug Evaluation and Research

ADVISORY COMMITTEE FOR PHARMACEUTICAL SCIENCE (ACPS)

May 3-4, 2005

CDER Advisory Committee Conference Room

5630 Fishers Lane

Rockville, MD

AGENDA

Day 1: Tuesday, May 3, 2005

8:30 Call to Order Charles Cooney, Ph.D.

Chair, ACPS

Conflict of Interest Statement Hilda Scharen, M.S.

Executive Secretary, ACPS

8:45 Introduction to Meeting

OPS Update

9:15 Establishing Drug Release or Dissolution

Specifications

10:30 Break

12:00 Lunch

1:00 Open Public Hearing

2:00 Establishing Drug Release or Dissolution

Specifications (Continued)

3:30 Break

Committee Discussions and Recommendations

4:30 Subcommittee Reports

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

Chair, Clinical Pharmacology Subcommittee

5:00 Adjourn

Food and Drug Administration

Center for Drug Evaluation and Research

ADVISORY COMMITTEE FOR PHARMACEUTICAL SCIENCE (ACPS)

May 3-4, 2005

CDER Advisory Committee Conference Room

5630 Fishers Lane

Rockville, MD

AGENDA

Day 2: Wednesday, May 4, 2005

8:30 Call to Order Charles Cooney, Ph.D.

Chair, ACPS

Conflict of Interest Statement Hilda Scharen, M.S.

Executive Secretary, ACPS

8:45 Parametric Tolerance Interval Test

for Dose Content Uniformity

Current update on the Working Group

9:15 Product Design and Pharmaceutical Equivalence

10:30 Break

12:00 Lunch

1:00 Open Public Hearing

2:00 Product Design and Pharmaceutical Equivalence

(Continued)

Committee Discussion and Recommendations

3:00 Break

3:15 Criteria for Establishing a Working Group for

Review and Assessment of OPS Research

Programs

Committee Discussion and Recommendations

4:30 Conclusion and Summary Remarks

5:00 Adjourn