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  • Title: Pharmacometrics and the transition to model-based development.
    Author: Grasela TH, Dement CW, Kolterman OG, Fineman MS, Grasela DM, Honig P, Antal EJ, Bjornsson TD, Loh E.
    Journal: Clin Pharmacol Ther; 2007 Aug; 82(2):137-42. PubMed ID: 17632539.
    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.
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