Food and Drug Administration
Center for Drug Evaluation and Research
ADVISORY COMMITTEE FOR PHARMACEUTICAL SCIENCE (ACPS)
CDER Advisory Committee Conference Room
Establishing Drug Release or Dissolution Specifications
Topic Introduction Ajaz Hussain, Ph.D.
Dissolution Measurement System: Lucinda Buhse, Ph.D.
Overview of Current Guidance Documents and Mehul Mehta, Ph.D.
Decision process: Biopharmaceutics Section Director, Division of Pharm. Evaluation I,
(OCPB), CDER, FDA
Establishing Dissolution Specifications: Vibhakar Shah, Ph.D.
Current Practice (CMC) Chemist, Division of New Drug Chemistry II
Open Public Hearing
USP and Dissolution Testing Will Brown
Department of Standards and Development
Establishing Drug Release or Dissolution Specifications (Continued)
Factors Impacting Drug Dissolution and
Summary of Tactical Plan Ajaz Hussain, Ph.D.
Clinical Pharmacology Subcommittee Jürgen Venitz, M.D., Ph.D.
(via teleconference) Chair, Clinical Pharmacology Subcommittee