Abstract

1. Challenges and opportunities in the field of biotransformation were presented and discussed at the 1st European Biotransformation workshop which was conducted virtually in collaboration with the DMDG 27 January 2021. Here we summarize the presentations and discussions from this workshop.

The following topics were covered:

• 2. Needs for radiolabel for IND filing versus quantitation without standards.

• 3. Applications of cyclic ion mobility in the field of biotransformation.

• 4. Computational predictions of xenobiotic metabolism.

• 5. Future (outsourcing) needs in biotransformation.

• 6. Genotoxicity risk assessment of metabolites and qualification of impurities using metabolite data.

• 7. Regulatory aspects of MIST.

摘要

1. 在 2021 年 1 月 27 日与 DMDG 虚拟合作举办的第一届欧洲生物转化研讨会上介绍和讨论了生物转化领域的挑战和机遇。在此我们总结了此次研讨会的演讲和讨论。

讨论了以下主题：

• 2. IND 备案需要放射性标记与无标准定量。

• 3. 循环离子淌度在生物转化领域的应用。

• 4. 异生物质代谢的计算预测。

• 5. 生物转化的未来（外包）需求。

• 6. 代谢物的遗传毒性风险评估和使用代谢物数据的杂质鉴定。

• 7. MIST 的监管方面。