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Advisory Committee for Pharmaceutical Science and Clinical Pharmacology (ACPS-CP)
July 23, 2008


  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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