The use of mass-spectrometry to support pharmacokinetic and pharmacodinamic studies during drug development

Seminario tenuto dal Dr Massimo BREDA (Director, Analytical and Bioanalytical Sciences, Pharmaceutical & Preclinical Development, APTUIT) nell'ambito del Corso di Dottorato in Biotecnologie.

Abstract
During drug development the quantitation of drug and its metabolites in animal and human biological matrices is requested to support pharmacokinetics and pharmacodynamics studies. The typical question to bioanalytical department is: what is the concentration of drugs and related metabolites in biological samples? The bioanalytical laboratories reply to this question using the same workflow and the same instrumental platform (LC-MS/MS) but with different strategies depending on the status of drug development. In this way the words Quality, Quantity, Quickness/Specificity assume different meaning to satisfy the discovery and development requirements. In this presentation examples of the sample preparation techniques of biological samples, of the MS/MS and chromatographic conditions set-up are shown. Moreover other applications of LC-MS/MS to support pharmacokinetic studies, like tissue analysis and plasma protein binding determination are reported. In conclusion, the use of LC-MS/MS technique for the evaluation of pharmacokinetics and pharmacodynamics studies of biologic drugs is discussed.