Clin Pharmacol Ther. 2007 Aug;82(2):137-42.

Pharmacometrics and the transition to model-based development.

Grasela TH, Dement CW, Kolterman OG, Fineman MS, Grasela DM, Honig P, Antal EJ, Bjornsson TD, Loh E.

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Cognigen Corporation, Williamsville, New York, USA. ted.grasela@cognigencorp.com

Abstract

As the transition to model-based drug development continues, pharmacometric analysis will have an increasingly important role across the entire life cycle of drug discovery, development, regulatory approval, and commercialization. For this reason, pharmacometrics can--and should--have an integrating function in the transformation to model-based development. This essay describes an approach for formalizing the pharmacometrics process using the disciplines encompassed by enterprise engineering.

PMID:: 17632539; [PubMed - indexed for MEDLINE]

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