Pharmacometrics and the transition to model-based development.
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.
Grasela
T H
TH
Cognigen Corporation, Williamsville, New York, USA. ted.grasela@cognigencorp.com
Dement
C W
CW
Kolterman
O G
OG
Fineman
M S
MS
Grasela
D M
DM
Honig
P
P
Antal
E J
EJ
Bjornsson
T D
TD
Loh
E
E
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