title: [Pharmaceutical aspects of clinical trials: concepts of pharmacokinetic investigations].
abstract: Pharmacokinetic investigations of a drug - and of its pharmacologically active metabolite, if necessary - represent an essential part of clinical trials. The European Union (EMEA, European Medicines Agency) strictly regulates the separation and quantification of a drug from biological matrix, e.g. blood, urine, tissue, and others. These GCP (Good Clinical Practice) and GLP (Good Laboratory Practice) guidelines have to be considered and documented for the planning of the investigation, the administration of the test drug, the sampling, and the transport of samples. The following sample preparation, analytical measurements, and biometric calculations have to be performed only by validated procedures. Similar requirements are necessary for the final pharmacokinetic modelling, the statistical presentation of data, and the final report. In this article the most important aspects concerning the performance of a pharmacokinetic investigation will be presented.
authors.affiliation: Department für Klinische Pharmazie und Diagnostik, Universität Wien, Osterreich. martin.czejka@univie.ac.at
authors.forename: Martin
authors.initials: M
authors.lastname: Czejka
mesh_terms: D001699:Biometry / Q000379:methods*; D002986:Clinical Trials as Topic / Q000592:standards*; D004341:Drug Evaluation / Q000592:standards*; D005062:European Union; D005858:Germany; D019983:Guideline Adherence / Q000458:organization & administration*; D010599:Pharmacokinetics; D010604:Pharmacy / Q000592:standards; D017410:Practice Guidelines as Topic; D012106:Research / Q000592:standards*