The 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.

中文翻译：

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小分子药物代谢物的合成和鉴定：为什么、何时以及如何？

药物发现和开发过程包括对药物生物转化产生的代谢物的研究。在这里，我们从专业合同研究组织的角度探讨小分子药物代谢物合成的原因、时间和方式，特别关注在此过程中与监管监督相关的项目。为了说明重要的方面，我们回顾了最近的案例研究、趋势和从过去十年中我们制造和识别代谢物的经验中学到的知识，以及从文献中精选的例子。