AAPS and FDA announce appointment of resea...(ntitled Enhancing Investigational New D...),Health

Date:4/14/2009

ntitled "Enhancing Investigational New Drug Application (IND)/New Drug Application (NDA) Review Quality via Quantifying Prior Knowledge," AAPS and the FDA will look to advance current research by supporting the development of Alzheimer's disease-state models. These disease-state models will be implemented by the FDA to review clinical trial data for clinical pharmacology, as well as statistical and clinical reviews. Another goal is to use modeling and simulation (M/S) technology to improve efficiency in the drug product development process. AAPS members have agreed to provide its expertise in quantitative modeling and simulation, while FDA staff will provide working experience of disease-state model use.

The AAPS Executive Council voted to support funding of the initiative in May of 2006 and it has been in development since that point. AAPS has pledged to contribute $200,000 over the 2-year research period to ORISE to cover the research process and salary of Dr. Faltaos. One principal investigator from each organization will also be involved in the research, with Dr. Gobburu representing the FDA's Office of Clinical Pharmacology and Dr. Sandra Allerheiligen representing AAPS.

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Contact: Tom Huddleston huddlestont@aaps.org 703-248-4744 American Association of Pharmaceutical Scientists Source:Eurekalert

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