ADVISORY COMMITTEE FOR PHARMACEUTICAL SCIENCE

October 21 - 22, 2003

 CDER Advisory Committee Conference Room

5630 Fishers Lane

Rockville, MD

 

AGENDA

Day 1: Tuesday, October 21, 2003

 

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

 

            Conflict of Interest                                           Hilda Scharen, Exec. Sec.

           

8:45     Introduction to Meeting                                    Helen Winkle, Director OPS

 

9:00     Subcommittee Reports

Manufacturing                                                 Judy Boehlert, Ph.D.                          

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

Pharmacology/Toxicology                                          

 

10:00   Draft PAT Guidance – Update                                 Ajaz Hussain, Ph.D.

                       

            Questions/Discussion

 

10:30   Break

           

10:45   Parametric Tolerance Interval Test for Dose Content Uniformity

           

            Overview and Issues                                                   Ajaz Hussain, Ph.D.

           

                       

11:30   Open Public Hearing

 

12:30   Lunch

 

1:30     Parametric Tolerance Interval Test for Dose Content Uniformity cont.

           

            Approaches for resolving identified issues                  Wallace Adams, Ph.D.

 

            IPAC-RS Presentations          

           

            (Break 2:30 – 2:45)    

 

            Committee Discussion and Recommendations

           

           

4:30     Adjourn

ADVISORY COMMITTEE FOR PHARMACEUTICAL SCIENCE

October 21 - 22, 2003

 CDER Advisory Committee Conference Room

5630 Fishers Lane

Rockville, MD

 

AGENDA

 

Day 2: Wednesday, October 22, 2003

 

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

 

            Conflict of Interest                                           Hilda Scharen, Exec.Sec.

 

8:45     Risk-based CMC Review Proposals

            Current thinking                                               Yuan-Yuan Chiu, Ph.D.

                                                                                    Vilayat Sayeed, Ph.D.

 

            Focus on “process understanding”                 Ajaz Hussain, Ph.D.

 

            Issues and challenges                         Moheb Nasr, Ph.D.

 

            Committee Discussion

           

10:15   Break

 

10:45   Nomenclature

            Proposals for resolving issues and

            challenges                                                       Moheb Nasr, Ph.D.

 

            FDA Perspective

 

            USP Perspective

 

            Committee discussion

 

12:00   Lunch

 

1:00     Open Public Hearing

 

2:00     Research for Generics - Bioequivalence of Topical Products

           

            Generic Drug Research Program                    Lawrence Yu, Ph.D.

 

            Dermatopharmacokinetics: Improvement of

            methodology for assessing bioequivalence

            of topical products                                           Annette L. Bunge, Ph.D.

 

            A case study of the effects of physical and

            rheological properties of deployment of

            topical products                                               David Katz, Ph.D.

 

            Bioequivalence of topical products: FDA

            Perspective                                                     Jonathan Wilkin, MD

 

            (3:00 – 3:15 Break)

 

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

 

5:00     Adjourn