Leveraging Prior Quantitative Knowledge to Guide Drug Development Decisions and Regulatory Science Recommendations: Impact of FDA Pharmacometrics During 2004-2006

Author:

Wang Yaning,Bhattaram A. Venkatesh,Jadhav Pravin R.,Lesko Lawrence J.,Madabushi Rajanikanth,Powell J. Robert,Qiu Wei,Sun He,Yim Dong S.,Zheng Jenny J.,Gobburu Jogarao V. S.

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Reference20 articles.

1. Food and Drug Administration Innovation or stagnation: challenges and opportunity on the critical path to new medical products March 2004 http:www.fda.govocinitiativescriticalpathwhitepaper.html

2. U.S. Department of Health and Human Services Food and Drug Administration, Center for Drug Evaluation and Research (CDER) October 2003 http:www.fda.govohrmsdocketsac03briefing3998B101Topic201-Part20A.pdf

3. Impact of pharmacometrics on drug approvals and labeling decisions: survey of 42 new drug applications;Bhattaram;AAPS J.,2005

4. Impact of pharmacokinetic review on new drug approval and labeling decisions-a survey of 31 new drug applications submitted between 2005 and 2006;Bhattaram;Clin Pharmacol Ther.,2007

5. Paving the critical path: how can clinical pharmacology help achieve the vision?;Lesko;Clin Pharmacol Ther.,2007

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