Food and Drug Administration
Center for Drug Evaluation and Research
ADVISORY COMMITTEE FOR PHARMACEUTICAL SCIENCE (ACPS)
CDER Advisory Committee Conference Room
Quality-by-Design and Pharmaceutical Equivalence
Topic Introduction Ajaz Hussain, Ph.D.
Using Product Development Information to Ajaz Hussain Ph.D.
Extend Biopharmaceutics Classification
Using Product Development Information
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
(OBP), OPS, CDER, FDA
CDER Peer Review Research Jerry Collins, Ph.D.
Office of Testing and Research (OTR), OPS, CDER, FDA
Topic Three Questions