Food and Drug Administration

Center for Drug Evaluation and Research



May 3, 2005

CDER Advisory Committee Conference Room

5630 Fishers Lane

Rockville, MD


Slides Presented



Establishing Drug Release or Dissolution Specifications


Topic Introduction                                                         Ajaz Hussain, Ph.D.

[HTM] [PPT]                                                                Deputy Director, OPS, CDER, FDA


            Dissolution Measurement System:                                    Lucinda Buhse, Ph.D.

Current State and Opportunities for Improvement  Director, Division of Pharmaceutical Analysis,

[HTM] [PPT]                                                                Office of Testing and Research (OTR), OPS, CDER,




            Overview of Current Guidance Documents and                 Mehul Mehta, Ph.D.

Decision process: Biopharmaceutics Section                      Director, Division of Pharm. Evaluation I,

[HTM] [PPT]                                                                 Office of Clinical Pharmacology and Biopharmaceutics

                                                                                    (OCPB), CDER, FDA


            Establishing Dissolution Specifications:                             Vibhakar Shah, Ph.D.

Current Practice (CMC)                                                  Chemist, Division of New Drug Chemistry II

[HTM] [PPT]                                                                 Office of New Drug Chemistry (ONDC),

            CDER, FDA


Open Public Hearing 

            USP and Dissolution Testing                                            Will Brown

            [HTM] [PPT]                                                                Staff Liaison to the Biopharmaceutics Expert Committee

                                                                                                Department of Standards and Development



Establishing Drug Release or Dissolution Specifications (Continued)


Factors Impacting Drug Dissolution and                           Lawrence Yu, Ph.D.

Absorption: Current State of Science                                Director for Science, Office of Generic Drugs

[HTM] [PPT]                                                                 (OGD), OPS, CDER, FDA


            Summary of Tactical Plan                                               Ajaz Hussain, Ph.D.

            [HTM] [PPT]


Subcommittee Reports

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

            (via teleconference)                                                        Chair, Clinical Pharmacology Subcommittee

            [HTM] [PPT]