Authors: Dr. Sneha Rathi, Mr. Arjun Mehta
Abstract: Pharmacokinetic and bioequivalence studies are essential components in the drug development process, ensuring safety, efficacy, and regulatory compliance of pharmaceuticals. These studies evaluate the absorption, distribution, metabolism, and excretion (ADME) of drugs, while bioequivalence studies assess the therapeutic equivalence between generic and reference formulations. Modern analytical tools, including High Performance Liquid Chromatography (HPLC), Liquid Chromatography Tandem Mass Spectrometry (LC-MS/MS), Ultra-Performance Liquid Chromatography (UPLC), and immunoassays, have transformed these studies by providing high sensitivity, selectivity, and accuracy. This paper discusses principles, sample preparation, analytical techniques, method validation, and applications of these tools in pharmacokinetic and bioequivalence studies. Integration of hyphenated techniques, automation, and computational approaches enhances throughput and reliability, supporting drug approval and therapeutic monitoring.
Keywords: Pharmacokinetics, Bioequivalence, HPLC, LC-MS/MS, UPLC, ADME, Analytical Methods
Full Issue
| View or download the full issue | PDF 60-65 |