Food and Drug Administration
Center for Drug Evaluation and Research
ADVISORY COMMITTEE FOR
PHARMACEUTICAL SCIENCE (ACPS)
CDER Advisory Committee Conference Room
Slides Presented
Quality-by-Design and Pharmaceutical
Equivalence
Topic Introduction Ajaz
Hussain, Ph.D.
Using Product Development Information to Ajaz Hussain
Ph.D.
Extend Biopharmaceutics Classification
System-based Biowaviers
Using Product Development Information
to
Address the Challenge of Highly-variable
Drugs
Using Product Development
Information to Robert Lionberger, Ph.D.
Support
Establishing Therapeutic Equivalence Chemist, OGD, OPS, CDER, FDA
of Topical Products
Criteria for Establishing a Working Group for
Review and Assessment of OPS Research Programs
CBER Peer Review Process for Kathleen A. Clouse, Ph.D.
Researchers/Reviewers Acting
Director, Division of Monoclonal
[HTML]
[PPT] Antibodies,
Office of Biotechnology Products
(OBP),
OPS, CDER, FDA
CDER Peer Review Research Jerry Collins, Ph.D.
[HTML] [PPT] Director,
Laboratory of Clinical Pharmacology,
Office of Testing and Research (OTR), OPS, CDER, FDA
Topic Three
Questions