Methodology for pharmacokinetic pharmacodynamic data analysis

This review will highlight the role of exploratory data analysis and nonlin ear regression software in pharmacokinetic-pharmacodynamic (PK/PD) data ana lysis. Kinetic and dynamic modelling situations typical to the pharmacokine ticist in the drug industry will be addressed, and two case studies, includ ing single-dose intravenous bolus plasma data and multiple-dose response-ti me 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 featur es of available commercial PK software will be given, Specific emphasis wil l be placed on the application of WinNonlin.