Author: Dr. Ritu Verma, Ankit Joshi
Abstract: Drug metabolite profiling has emerged as a critical component in drug discovery and development, providing detailed insights into pharmacokinetics, toxicity, and therapeutic efficacy of candidate compounds. By characterizing metabolites formed after drug administration, researchers can predict drug behavior, optimize lead compounds, and minimize adverse effects. This paper explores the role of metabolite profiling using advanced analytical techniques such as LC-MS/MS, GC-MS, NMR, and high-resolution mass spectrometry. It emphasizes regulatory requirements, the importance of identifying active and toxic metabolites, and the integration of metabolite data into decision-making during early and late-stage drug development. Case studies and tables illustrate the practical applications of metabolite profiling, demonstrating its significant impact on efficient and safe drug development.
Keywords: Drug metabolism, Metabolite profiling, LC-MS/MS, Pharmacokinetics, Drug development
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