ADVISORY COMMITTEE FOR PHARMACEUTICAL SCIENCE

October 21 - 22, 2002

CDER Advisory Committee Conference Room

5630 Fishers Lane

Rockville, MD

Day 1: Monday, October 21, 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 Subcommittee Reports

9:00 Non-Clinical Studies Frank Sistare, Ph.D.
Robert Osterberg, Ph.D.

9:45 Process Analytical Technologies Thomas Layloff, Ph.D.

10:30 Break

10:45 Other Updates

10:45 Risk Based CMC Review Yuan-yuan Chiu, Ph.D.
Vilayat Sayeed, Ph.D.

11:15 Blend Uniformity Ajaz Hussain, Ph.D.

Invited Guests:

Tobias Massa, Ph.D., Eli Lilly
Thomas Garcia, Ph.D., Pfizer

11:45 Open Public Hearing

12:45 Lunch

1:45 Regulatory issues related to crystal habits - polymorphism

1:45 Introduction Gary Buehler, R.Ph.

2:00 Scientific considerations of pharmaceutical
solid polymorphism Lawrence Yu, Ph.D.

2:45 Expert comments

Kenneth R Morris, Ph.D. Purdue
Harry G. Brittain, Ph.D. Center for Pharmaceutical Physics
Leslie Benet, Ph.D. UCSF

3:15 Break

3:30 Polymorphism cont.

Committee Discussion

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

5:00 Adjourn