Monitoring Molecules in Complex Biological Matrices Using Hyphenated Chromatographic Techniques and Their Applications

Abstract

Title: MONITORING MOLECULES IN COMPLEX BIOLOGICAL MATRICES USING HYPHENATED CHROMATOGRAPHIC TECHNIQUES AND THEIR APPLICATIONS Discovering novel medicinal entities (NMEs) and their clinical development is challenging. It involves various risk based processes for their safety and efficacy evaluation in pre-clinical species and comparing their translatability to humans during clinical trials. One of the major reason for failure of drug candidate in the developmental phase is attributed to lack of efficacy or safety. The efficacy and safety of the drugs depends on concentrations available in target organ or biological newlinematrix. The pharmacokinetic parameters alculated from the monitored concentration in different biological matrices are of immense help in understanding or bringing the correlation between the efficacy and safety newlineof the molecule. Each molecule has its unique way of penetration into various biological matrices. Hence, monitoring the concentrations in relevant biological matrices is of paramount importance during the various stages of drug discovery and development. The interest of biological matrix depends on the localization of target receptors or enzymes or area of disease progression. Among the targets, drugs to treat the central nervous system disorders (CNS) or prevention of human immunodeficiency virus (HIV) infection from mother-to-child involve x number of steps in development and it involves exposure measurement in less frequently used complex matrices. Hence the ork presented in this thesis describes the exposure assessment in various biological newlinematrices belong to above mentioned herapeutic areas for discovering the drugs for specific unmet medical need.