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U.S. Department of Health and Human Services

Advisory Committees

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Slides for the August 4, 2009 Meeting of the Pharmaceutical Science and Clinical Pharmacology Advisory Committee



Topic Introduction (pdf)

Robert A. Lionberger, Ph.D.

Chemist, Office of Generic Drugs (OGD), OPS, CDER, FDA


Update on the Changing Epidemiology of Clostridium difficile Infections (pdf)

LawrenceC. McDonald, M.D.

Centers for Disease Control, Atlanta, Georgia


Bioequivalence: The Critical Role of Dissolution (pdf)

Gordon L. Amidon, Ph.D.

Professor of Pharmacy and Professor of Pharmaceutical Science, the University of Michigan


FDA Recommendation for Vancomyci HCl Capsule BE Studies (pdf)

Barbara M. Davit, Ph.D., J.D.

Acting Director, Division of Bioequivalence 2






ViroPharma Incorporated (pdf)


Generic Industry Positions (pdf)

(Akorn, Inc., Impax Laboratories, Inc., Mylan Pharmaceuticals Inc.,

Paddock Laboratories, Inc., Sandoz Inc., Strides Arcolab Limited,

Teva Pharmaceuticals USA, Watson Pharmaceuticals, Inc)


Presentation by:

Scientific Perspective

Russell J. Rackley, Ph.D. (pdf)

Vice President, Pharmacokinetics/Drug Metabolism,

Mylan Pharmaceuticals Inc.


Clinical Pharmacy Perspective

Douglas Slain, Pharm.D., BCPS, FCCP

Associate Professor, West Virginia University


Medical Perspective

Dale L. Coy, M.D., FACG

Division of Gastroenterology

Advocate Healthcare System, Chicago, IL



Open Public Hearing


OPH 1: (pdf)