Food and Drug Administration

Center for Drug Evaluation and Research



May 4, 2005

CDER Advisory Committee Conference Room

5630 Fishers Lane

Rockville, MD


Slides Presented






Quality-by-Design and Pharmaceutical Equivalence


            Topic Introduction                                                        Ajaz Hussain, Ph.D.

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Using Product Development Information to                   Ajaz Hussain Ph.D.

Extend Biopharmaceutics Classification            

System-based Biowaviers                                            



            Using Product Development Information to                   Lawrence Yu, Ph.D.

            Address the Challenge of Highly-variable Drugs

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            Using Product Development Information to                   Robert Lionberger, Ph.D.

            Support Establishing Therapeutic Equivalence    Chemist, OGD, OPS, CDER, FDA

            of Topical Products

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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

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