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journal article Dec 01, 2004

Population Pharmacokinetics III: Design, Analysis, and Application of Population Pharmacokinetic Studies

Ene I Ette Paul J Williams James R Lane
Annals of Pharmacotherapy Vol. 38 No. 12 pp. 2136-2144 · SAGE Publications
View at Publisher Save 10.1345/aph.1e260
Abstract
OBJECTIVE To present a framework within which population pharmacokinetic (PPK) studies should be designed and analyzed and discuss the application of developed PPK models. METHODS Information on PPK was retrieved from a MEDLINE search (1979–December 2003) of the literature and a bibliographic evaluation of review articles and books. This information is used in conjunction with experience to explain the design and analysis of PPK studies. Also, examples are included to demonstrate the usefulness of PPK. SYNTHESIS A great deal of thought must be given to the design and analysis of PPK studies (ie, development of PPK models). Models are of 2 primary types—descriptive and predictive—and the process applied to these models is necessarily different. An approach that ensures model applicability is presented. CONCLUSIONS PPK models have great utility, and the applications are many. They are very different from single-subject pharmacokinetic models and therefore require different approaches to model estimation.
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Details
Published
Dec 01, 2004
Vol/Issue
38(12)
Pages
2136-2144
License
View
Authors
E
Ene I Ette

Ene I Ette MSc PhD FCP FCCP, Senior Director of Clinical Pharmacology, Vertex Pharmaceuticals, Inc., Cambridge, MA

P
Paul J Williams

Paul J Williams PharmD MS FCP FCCP, Professor of Pharmacy, Department of Pharmacy Practice, School of Pharmacy, University of the Pacific; Trials by Design, LLC, Stockton, CA

J
James R Lane

James R Lane PharmD, Associate Professor, Department of Pharmacy Services, University of California San Diego Medical Center, San Diego, CA

Cite This Article
Ene I Ette, Paul J Williams, James R Lane (2004). Population Pharmacokinetics III: Design, Analysis, and Application of Population Pharmacokinetic Studies. Annals of Pharmacotherapy, 38(12), 2136-2144. https://doi.org/10.1345/aph.1e260
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