QUICK SEARCH:   [advanced] Author: Keyword(s): Year:  Vol:  Page:

This Article Résumé Extracto Full Text PDF Alert me when this article is cited Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Articles Ahead of Print [Order Reprint] Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Ette, E. I Articles by Lane, J. R Search for Related Content PubMed PubMed Citation Articles by Ette, E. I Articles by Lane, J. R

PHARMACOKINETICS

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

Senior Director of Clinical Pharmacology, Vertex Pharmaceuticals, Inc., Cambridge, MA

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

James R Lane, PharmD

Associate Professor, Department of Pharmacy Services, University of California San Diego Medical Center, San Diego, CA

Reprints: Ene I Ette MSc PhD FCP FCCP, Vertex Pharmaceuticals, Inc., 130 Waverly St., Cambridge, MA 02139-4242, fax 617/444-6713, Ene_Ette{at}vrtx.com

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.

Key Words: population pharmacokinetics, study design

Published Online, October 26, 2004. www.theannals.com, DOI 10.1345/aph.1E260

This article has been cited by other articles:

				L. Zeng, C. E. Nath, E. Y. L. Blair, P. J. Shaw, K. Stephen, J. W. Earl, J. C. Coakley, and A. J. McLachlan Population Pharmacokinetics of Acyclovir in Children and Young People with Malignancy after Administration of Intravenous Acyclovir or Oral Valacyclovir Antimicrob. Agents Chemother., July 1, 2009; 53(7): 2918 - 2927. [Abstract] [Full Text] [PDF]

				B. Punyawudho, R. E. Ramsay, F. M. Macias, A. J. Rowan, J. F. Collins, R. C. Brundage, and A. K. Birnbaum Population Pharmacokinetics of Lamotrigine in Elderly Patients J. Clin. Pharmacol., April 1, 2008; 48(4): 455 - 463. [Abstract] [Full Text] [PDF]

				B. G. Charles, A. K. Miller, P. E. Nasveld, M. G. Reid, I. E. Harris, and M. D. Edstein Population Pharmacokinetics of Tafenoquine during Malaria Prophylaxis in Healthy Subjects Antimicrob. Agents Chemother., August 1, 2007; 51(8): 2709 - 2715. [Abstract] [Full Text] [PDF]