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FAQ – It’s time to answer the key points and challenges in API Quality Research!

  API quality research is not only a technical discussion but also a core issue concerning the safety and efficacy of medications.  In modern pharmaceutical research, it is crucial to fully understand the properties and characteristics of APIs, ensure consistency and stability in the manufacturing process, and improve the quality and reliability of medications.  During API quality research, many challenges arise: how to handle issues when they occur, which guidelines to follow, and how to deal with supplementary data requests. Medicilon’s Cloud Lecture Hall invites Jianmei Wang from the Process Department to provide a comprehensive and in-depth analysis of API quality research from multiple perspectives.  Jianmei will address potential issues in API quality research and explain how to effectively handle them one by one. 01 How should the deuteration ratio of deuterated drugs be studied? Are there any relevant guidelines that can be referenced? What are...