title: Methodology for pharmacokinetic/pharmacodynamic data analysis.
abstract: This review will highlight the role of exploratory data analysis and nonlinear regression software in pharmacokinetic-pharmacodynamic (PK/PD) data analysis. Kinetic and dynamic modelling situations typical to the pharmacokineticist in the drug industry will be addressed, and two case studies, including single-dose intravenous bolus plasma data and multiple-dose response-time data will be analysed. Approaches to assessing the suitability of model fit to the observed data will be discussed, and a summary of the key features of available commercial PK software will be given. Specific emphasis will be placed on the application of WinNonlin.
authors.affiliation: Department of Drug Metabolism and Pharmacokinetics, Astra Arcus AB, S-151 85 Södertälje, Sweden.
authors.initials: JL
authors.lastname: Gabrielsson
authors.initials: DL
authors.lastname: Weiner