ADVISORY COMMITTEE FOR PHARMACEUTICAL SCIENCE

May 7-8, 2002

CDER Advisory Committee Conference Room

5630 Fishers lane

Rockville, MD

AGENDA

Day 1: Tuesday, May 7, 2002

8:30 Call to Order Vincent H. L. Lee, Ph.D., Acting Chair

Conflict of Interest Kathleen Reedy, Exec. Sec

8:45 Introduction to Meeting Helen Winkle, Acting Director OPS

9:00 Future Sub-committees

Introduction and Overview Ajaz Hussain, Ph.D. Deputy Director, OPS

Clinical Pharmacology
Pharmacology/Toxicology
Other

Committee Discussions

9:45 Break

10:00 Draft Guidance: Food Effect BE Studies

Introduction and Overview Dale Conner, Pharm.D. OPS/OGD

Science Background and Issues Ameeta Parekh, Ph.D. OPS/OCPB

Invited Guests

Aziz Karim, Ph.D. Takeda

Ian Wielding, Ph.D. Pharmprofiles

11:30 Open Public Hearing

12:30 Lunch

1:30 Biopharmaceutics Classification System - Next Steps

Introduction and Overview Lawrence Yu, Act. Deputy Director for Science, OGD/OPS

Presentations Gordon Amidon, Ph.D. Univ. Michigan

Jack Cook, Ph.D. Pfizer

3:15 Break

3:30 Committee Discussions

4:30 Adjourn

ADVISORY COMMITTEE FOR PHARMACEUTICAL SCIENCE

May 7-8, 2002

CDER Advisory Committee Conference Room

5630 Fishers lane

Rockville, MD

AGENDA

Day 2: Wednesday, May 8, 2002

8:30 Call to Order Vincent H. L. Lee, Ph.D., Acting Chair

Conflict of Interest Kathleen Reedy, Exec. Sec

8:45 Process Analytical Technology

Introduction and Overview Ajaz Hussain, Ph.D. Deputy Director, OPS

Sub-Committee Report and Next Steps Tom Layloff, Ph.D.

Committee Discussions

10:30 Break

10:45 Rapid Microbial Testing - Update

Introduction and Overview David Hussong, Ph.D. OPS

Bryan Riley, Ph.D. OPS

Presentation Michael S. Korczynski, Ph.D. Mikkor

Committee Discussions

11:30 Open Public Hearing

12:30 Lunch

1:30 Blend Uniformity

Introduction and Overview Ajaz Hussain, Ph.D., Deputy Director, OPS

Presentations Tobias Massa, Ph.D. Eli Lilly

Thomas Garcia, Ph.D. Pfizer

Committee Discussions

2:45 Break

3:00 Regulatory Issues related to crystal habits - polymorphism

Introduction and Overview Yuan-yuan Chiu, Director ONDC

ONDC Issues Steve Miller, Ph.D. OPS/ONDC

OGD Issues Richard Adams, Ph.D. OPS/OGD

Other Regulatory perspectives Harry G. Brittain, Ph.D.

Center for Pharmaceutical Physics

Invited Guests

Kenneth R Morris, Ph.D. Purdue

Committee Discussions

4:30 OPS Updates and Topics for the next meeting

5:00 Adjourn