Abstract

Mass spectrometry alone or in combination with liquid chromatography has become the analytical tool by choice to achieve therapeutic peptide quantitation in biological samples. Because of the challenge that entails to embrace more than 85% of the concentration time curve during pharmacokinetics studies, all strategies involving the peptide quantitation in biological fluids are still a difficult task and need to be tailored. We present here our recent experiences in the development and validation of customized bioanalytical methods applied to pharmacokinetic studies included in phase I clinical trials. All methodologies were optimized case by case for CIGB-500, CIGB-300 and CIGB-814 therapeutic peptide candidates developed at the Centre for Genetic Engineering and Biotechnology, from Havana (Cuba). The three bioanalytical methods were fully validated according to the FDA guidelines for industry. It was possible to obtain the PK profiles and main PK parameters for all of the assessed candidates.