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共同加工的活性制药成分的稳定性研究的监管考虑因素

Robert K Orr1, Thimma Rawalpally2, Lindsey Saunders Gorka3

  • 1Global Regulatory Affairs, Chemistry Manufacturing and Controls, Merck & Co., Inc., 126 E. Lincoln Ave, PO Box 2000, Rahway, New Jersey, 07065, USA. robert.orr@merck.com.

The AAPS journal
|December 17, 2024
PubMed
概括

共同加工的活性药物成分 (CP API) 提供了好处,但面临着监管的模糊性. 本文提出了CP API及其产品的明确稳定性研究指南,以帮助更广泛的行业采用.

关键词:
无形固体的分散性固体.协同晶体是一种共晶体.同加工的活性药物成分是同加工的活性药物成分.监管事务 监管事务稳定的稳定性 稳定的稳定性

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