ADVISORY COMMITTEE FOR PHARMACEUTICAL SCIENCE

 

March 12-13, 2003

 CDER Advisory Committee Conference Room

5630 Fishers Lane

Rockville, MD

 

AGENDA

 

Day 2: Thursday, March 13, 2003

 

8:30     Call to Order                                                               Art Kibbe, Ph.D., Chair

 

            Conflict of Interest                                                       Kathleen Reedy Exec.Sec.

 

8:45     Research in OPS                                                     

            Introduction                                                                 Ajaz Hussain, Ph.D.                           

OPS Rapid Response Projects                                 Nakissa Sadrieh, Ph.D.

 

10:00   Break

 

10:15   Dose Content Uniformity -                                      Wallace Adams, Ph.D.

Parametric Tolerance Interval Test

for Aerosol Products

            Guest Presenter - Bo Olsson, Ph.D.

            Guest Discussant - Walter Hauck, Ph.D.

 

11:30   Open Public Hearing

                       

12:00   Lunch

 

1:00     Bioequivalence / Bioavailability of Endogenous Drugs

                        Presenters:

                        Dale Conner, Pharm.D.

                        Steven Johnson, Ph.D.

 

                        Guest Presenter -                  

 

2:30     Break

 

2:45     Bioequivalence / Bioavailability of Endogenous Drugs cont.

                                               

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

 

5:00     Adjourn