ADVISORY COMMITTEE FOR PHARMACEUTICAL SCIENCE
October 21 - 22, 2002
CDER Advisory Committee Conference Room
5630 Fishers Lane
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.
10:45 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.
Tobias Massa, Ph.D., Eli Lilly
Thomas Garcia, Ph.D., Pfizer
11:45 Open Public Hearing
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
3:30 Polymorphism cont.
4:45 Conclusions and Summary Remarks Ajaz Hussain, Ph.D.