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Pharmacometrics and the Transition to Model‐Based Development
Author(s) -
Grasela T H,
Dement C W,
Kolterman O G,
Fineman M S,
Grasela D M,
Honig P,
Antal E J,
Bjornsson T D,
Loh E
Publication year - 2007
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1038/sj.clpt.6100270
Subject(s) - clinical pharmacology , drug development , commercialization , process (computing) , function (biology) , computer science , engineering ethics , management science , pharmacology , medicine , drug , engineering , political science , biology , law , programming language , evolutionary biology
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. Clinical Pharmacology & Therapeutics (2007) 82 137–142. doi: 10.1038/sj.clpt.6100270