title: Pharmacometrics and the transition to model-based development.
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.
authors.affiliation: Cognigen Corporation, Williamsville, New York, USA. ted.grasela@cognigencorp.com
authors.forename: T H
authors.initials: TH
authors.lastname: Grasela
authors.forename: C W
authors.initials: CW
authors.lastname: Dement
authors.forename: O G
authors.initials: OG
authors.lastname: Kolterman
authors.forename: M S
authors.initials: MS
authors.lastname: Fineman
authors.forename: D M
authors.initials: DM
authors.lastname: Grasela
authors.forename: P
authors.initials: P
authors.lastname: Honig
authors.forename: E J
authors.initials: EJ
authors.lastname: Antal
authors.forename: T D
authors.initials: TD
authors.lastname: Bjornsson
authors.forename: E
authors.initials: E
authors.lastname: Loh
mesh_terms: D000818:Animals; D003198:Computer Simulation; D017277:Drug Approval / Q000379:methods / Q000706:statistics & numerical data; D015195:Drug Design; D004346:Drug Information Services / Q000706:statistics & numerical data* / Q000639:trends; D006801:Humans; D008962:Models, Theoretical; D010601:Pharmacology, Clinical / Q000379:methods / Q000706:statistics & numerical data* / Q000639:trends