SPARSE DRUG CONCENTRATION DATA-ANALYSIS USING A POPULATION APPROACH -A VALUABLE TOOL IN CLINICAL-PHARMACOLOGY

1. Drug concentration or pharmacological effect data collected from pa tients during therapy or as part of a Phase III or post-marketing stud y are generally sparse (i.e. one or a few observations per patient) in nature. 2. The population approach to analysing sparse drug concentra tion data provides a valuable tool for obtaining information about the pharmacokinetics of drugs in special patient groups (neonates, aged o r critically ill), the importance of drug interactions in the clinic ( using routinely collected blood concentration data) and for conducting a 'pharmacokinetic screen' in patients during early phase efficacy tr ials. 3. Using a population approach to analyse drug concentration-tim e data collected from patients during therapy or during an early phase investigation can complement information obtained from traditional ph armacokinetic/dynamic investigations to help gain a further insight in to the factors that influence dosing guidelines.