Food and Drug Administration
Center for Drug Evaluation and Research
ADVISORY COMMITTEE FOR
PHARMACEUTICAL SCIENCE (ACPS)
CDER Advisory Committee Conference Room
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.
[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
Absorption:
[HTM] [PPT] (OGD),
OPS, CDER, FDA
Summary
of Tactical Plan Ajaz Hussain, Ph.D.
Subcommittee Reports
Clinical Pharmacology Subcommittee Jürgen Venitz, M.D.,
Ph.D.
(via teleconference) Chair,
Clinical Pharmacology Subcommittee