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Comment

. 2008 Feb;48(2):144-5.

doi: 10.1177/0091270007313560.

Communicating with the FDA: the "third rail" of a new model for drug development

Donald R Stanski¹, John J Orloff

Affiliations

PMID: 18199890
DOI: 10.1177/0091270007313560

Comment

Communicating with the FDA: the "third rail" of a new model for drug development

Donald R Stanski et al. J Clin Pharmacol. 2008 Feb.

. 2008 Feb;48(2):144-5.

doi: 10.1177/0091270007313560.

Authors

Donald R Stanski¹, John J Orloff

Affiliation

¹ Global Head Modeling and Simulation, Novartis Pharmaceuticals Corporation, One Health Plaza, East Hanover, NJ 07936-1080, USA. donald.stanski@novartis.com

PMID: 18199890
DOI: 10.1177/0091270007313560

No abstract available

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Leveraging prior quantitative knowledge to guide drug development decisions and regulatory science recommendations: impact of FDA pharmacometrics during 2004-2006.
Wang Y, Bhattaram AV, Jadhav PR, Lesko LJ, Madabushi R, Powell JR, Qiu W, Sun H, Yim DS, Zheng JJ, Gobburu JV. Wang Y, et al. J Clin Pharmacol. 2008 Feb;48(2):146-56. doi: 10.1177/0091270007311111. J Clin Pharmacol. 2008. PMID: 18199891

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