Modern Trends In Bioanalytical Techniques for Pharmacokinetic and Toxicokinetic Studies

Abstract

Abstract The development of new therapeutic entities necessitates accurate and sensitive bioanalytical techniques to assess their pharmacokinetic (PK) and toxicokinetic (TK) profiles. This paper explores the recent advancements in bioanalytical tools used for quantifying drug concentrations in biological matrices. Techniques such as LC-MS/MS, electrochemical biosensors, and dried blood spot (DBS) sampling are evaluated in terms of sensitivity, selectivity, and throughput. Emphasis is placed on method validation criteria, sample preparation strategies, and assay reproducibility. The role of regulatory bodies such as the USFDA and EMA in shaping bioanalytical method validation protocols is also discussed. Through case studies of anti cancer and anti-diabetic drugs, the paper underscores the importance of robust analytical design in assessing drug behavior in vivo. The discussion concludes with an outlook on future trends like miniaturized sampling devices and artificial intelligence-driven data analytics in bioanalysis.

Keywords: Quality by Design, Bioanalytical Methods, Pharmacokinetics, LC MS/MS, Drug Quantification, Regulatory Validation