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Dockets Management

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Food and Drug Administration

Center for Drug Evaluation and Research

Pharmaceutical Science (ACPS) 

October 19, 2006



Portions of this document have been determined to be exempt from disclosure under the Freedom of Information Act (the FOIA) (5 U.S.C. §552).
 These redacted portions will appear as white space on the screen or on the printed page.

Topic III:  Using Disease, Placebo, and Drug Prior Knowledge to Improve Decisions

Decisions in Drug Development and at FDA: How Combining Prior Knowledge with Quantitative-based Decisions Can Improve Productivity and Quality, Bob Powell, Ph.D., FDA (htm) (ppt)

Impact of Prior Knowledge on Drug Development Decisions: Case Studies Across Companies, Ph.D., Quantitative Solutions Inc. (htm) (ppt)

Disease Models at FDA: Overview and Case Studies (Diabetes and Obesity), Joga Gobburu, Ph.D., FDA (htm) (ppt)

Disease Models at FDA:  Parkinson’s disease, Atul Bhattaram, Ph.D., and Ohid Siddiqui, Ph.D., FDA (htm) (ppt)

Open Public Hearing

NDA Partners LLC, Carl Peck, M.D.

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