ADVISORY COMMITTEE FOR PHARMACEUTICAL SCIENCE

Clinical Pharmacology Subcommittee

CDER Advisory Committee Conference Room

April 22 -  23, 2003

 5630 Fishers Lane

Rockville, MD

 

DRAFT AGENDA

 

Day 1 - April 22, 2003

 

8:30     Call to Order                                                 Jurgen Venitz, M.D., Ph.D., Chair

 

            Conflict of Interest                                           Kathleen Reedy, Exec.Sec.

 

8:45     Introduction to Meeting                   Lawrence Lesko, Ph.D., Director OCBP

 

9:00     Topic # 1 Quantitative risk analysis using

exposure-response for determining dose

adjustment for special populations                             Peter Lee, Ph.D.

 

9:10     Example 1                                                       Nhi Nguyen,  Ph.D.

 

            9:30     Example 2                                                       Jenny J. Zheng, Ph.D.

                                                                       

(9:50 - 10:10    Break)

 

10:10   Committee discussion

 

11:00   Example 3                                                       He Sun., Ph.D.

 

11:20   Committee discussion

 

11:45   Lunch

 

12:45   Open Public Hearing

 

1:15     Topic #1 cont.

 

1:15     Example 4  - Optimizing dosing strategies

for defined therapeutic targets                        Mats Karlsson, Ph.D.

 

1:40     Committee discussion

 

2:10     Topic # 2 Pediatric population pharmacokinetics

study design template and analyses of the FDA

pediatric database                                                    Lawrence Lesko, Ph.D.

 

2:20     Pediatric PPK template                                  Peter Lee, Ph.D.

 

            2:35     Committee discussion

           

(3:05 - 3:30 Break)

 

3:20     Pediatric Database Analysis                                       Gene Williams, Ph.D.

 

3:35     Committee Discussion

               

4:00     Concluding Remarks - First Day Meeting                         Lawrence Lesko, Ph.D.

 

5:00     Adjourn