Food and Drug Administration

Center for Drug Evaluation and Research

ADVISORY COMMITTEE FOR PHARMACEUTICAL SCIENCE (ACPS)

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,

FDA

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]