赵娜, 石靖*. 口服固体仿制药体外一致性评价中的非常规研究及常见问题解析J. 药学学报, 2021,56(6): 1739-1744. doi: 10.16438/j.0513-4870.2021-0123
引用本文: 赵娜, 石靖*. 口服固体仿制药体外一致性评价中的非常规研究及常见问题解析J. 药学学报, 2021,56(6): 1739-1744. doi: 10.16438/j.0513-4870.2021-0123
ZHAO Na, SHI Jing*. The analysis of unconventional research projects and common problems in the in vitro consistency evaluation of oral solid generic drugsJ. Acta Pharmaceutica Sinica, 2021,56(6): 1739-1744. doi: 10.16438/j.0513-4870.2021-0123
Citation: ZHAO Na, SHI Jing*. The analysis of unconventional research projects and common problems in the in vitro consistency evaluation of oral solid generic drugsJ. Acta Pharmaceutica Sinica, 2021,56(6): 1739-1744. doi: 10.16438/j.0513-4870.2021-0123

口服固体仿制药体外一致性评价中的非常规研究及常见问题解析

The analysis of unconventional research projects and common problems in the in vitro consistency evaluation of oral solid generic drugs

  • 摘要: 本文结合《化学药品仿制药口服固体制剂质量和疗效一致性评价申报资料要求(试行)》等相关技术要求,概括并拟定了口服固体仿制药体外一致性评价的决策树,论述了不同情况下体外评价考察项目的差异和常见问题,重点分析了非常规研究项目的技术要求和关注问题,并提出相应的处理建议,旨在为后续口服固体仿制药一致性评价的研究提供更多的参考。

     

    Abstract: Based on the "requirements on the submitted documents for consistency evaluation of generic oral solid dosage forms of chemical drugs" and relevant guidance, this article summarized and formulated the decision tree of in vitro consistency evaluation of oral solid generic drugs, discussed the differences and common problems of in vitro evaluation research projects under different conditions, selective analyzed the technical requirements and concern problems of unconventional research projects, and proposed corresponding recommendations for concern problems, in order to provide more references for the follow-up study on consistency evaluation of oral solid generic drugs.

     

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