Small molecule drug metabolite synthesis and identification: why, when and how?

Drug Discov Today. 2024 Mar 5:103943. doi: 10.1016/j.drudis.2024.103943. Online ahead of print.ABSTRACTThe drug discovery and development process encompasses the interrogation of metabolites arising from the biotransformation of drugs. Here we look at why, when and how metabolites of small-molecule drugs are synthesised from the perspective of a specialist contract research organisation, with particular attention paid to projects for which regulatory oversight is relevant during this journey. To illustrate important aspects, we look at recent case studies, trends and learnings from our experience of making and identifying metabolites over the past ten years, along with with selected examples from the literature. Teaser: The impact of drug metabolites in clinical development, regulatory obligations, and how diverse and challenging problems were solved in real-life examples.PMID:38452922 | DOI:10.1016/j.drudis.2024.103943
Source: Drug Discovery Today - Category: Drugs & Pharmacology Authors: Source Type: research