Food and Drug
Administration
Center for Drug Evaluation and Research
Pharmaceutical
Science (ACPS)
October 19, 2006
Slides
Disclaimer
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).
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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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