Preanalytical considerations in drug assays in clinical pharmacokinetic studies.

Many hospital pharmacy laboratories undertake drug analysis in biological fluids for the production of pharmacokinetic data. The success of such an undertaking very much depends on the selection of a suitable analytical method and a proper approach to sample collection and handling. This paper surveys the main types of biological specimens taken from the patients for pharmacokinetic drug analysis and discusses factors that affect them during or subsequent to their removal. Guidelines are provided in specimen handling and dealing with many problems which could arise prior to actual analysis. By its very nature this paper brings in many disciplines, the full details of which are well beyond its scope, however, some discussion on pharmacokinetic and bioavailability methods in relation to sampling procedures is included to put the matter into a proper perspective.