Population Pharmacokinetics I: Background, Concepts, and Models

Author:

Ette Ene I1,Williams Paul J2

Affiliation:

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

2. 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

Abstract

OBJECTIVE To present and emphasize the background, foundations, utility, and conceptual underlying theory of the population pharmacokinetic (PPK) approach with an examination of the advantages when compared with other approaches of pharmacokinetic modeling. DATA SOURCES Information on PPK was retrieved from a MEDLINE search (1979—June 2002) of literature and a bibliographic review of review articles and books. STUDY SELECTION AND DATA EXTRACTION All articles identified from data sources were evaluated and relevant information was included in this review. DATA SYNTHESIS PPK plays a pivotal role in developing dosing strategies for direct patient care and in drug development. PPK is valuable because it targets the patient group that will eventually receive the drug of interest, quantitates pharmacokinetic variability at several levels, and seeks to explain those sources of variability. 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 development.

Publisher

SAGE Publications

Subject

Pharmacology (medical)

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