Ene I Ette1, Paul J Williams. 1. Vertex Pharmaceuticals, Inc., Cambridge, MA, USA. Ene_Ette@vpharm.com
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.
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.