Advisory
Committee for Pharmaceutical Science and Clinical Pharmacology (ACPS-CP)
July 23, 2008
SLIDES
TOPIC 1:
Bioequivalence Methods for Locally Acting Drugs that Treat Gastrointestinal
(GI) Conditions
Food and Drug Administration Presentations
Lawrence
Yu, Ph.D., Director for Science, OGD/OPS/CDER/FDA (ppt) (html)
Robert Lionberger, Ph.D., OGD/OS/CDER/FDA (ppt) (html)
Guest Speaker Presentations
James Polli,
Ph.D.,
University
of
Maryland
School
of
Pharmacy
(ppt) (html)
OPH Presentations
Speaker # 1
(ppt) (html)
Speaker # 2
(ppt) (html)
Speaker # 3
(ppt) (html)
TOPIC 2: Drug
Classification of Orally Disintegrating Tablets (ODT)
Food and Drug Administration Presentations
Frank O.
Holcombe, Ph.D., OGD/OPS/CDER/FDA (ppt)
(html)
TOPIC 3: Use
of Inhaled Corticosteroid Dose Response as a Means to Establish Bioequivalence
of Inhalation Drug Products
Food and Drug Administration Presentations
Lawrence
Yu, Ph.D., Director, OGD/OPS/CDER/FDA
(ppt) (html)
Wallace P.
Adams, Ph.D., OGD/OPS/CDER/FDA (ppt)
(html)
Badrul A.
Chowdhury, M.D, Ph.D., OGD/OPS/CDER/FDA (ppt) (html)
OPH Presentation
Speaker # 4
(ppt) (html)
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