目的 结合刻痕片的临床使用现状与国内外对刻痕片的技术要求,探讨刻痕片的技术要求。方法 重点介绍FDA发布的关于片剂刻痕的指南,在此基础上提出对国内仿制药刻痕片技术要求的一般考虑。结果与结论 研发过程中应充分考虑产品特性建立评价标准,结合临床需求开发片剂刻痕,规范说明书描述以明确刻痕片临床使用。
Abstract
OBJECTIVE To discuss the technical requirements of scored tablets combining with the current situation of clinical use of scored tablets and the domestic and national technical requirements. METHODS The FDA guidance on tablet scoring was introduced in detail, on this basis, the general considerations on the technical requirements of generic scored tablets were put forward. RESULTS AND CONCLUSION It was suggested that the evaluation criteria should be established on the basis of taking a full consideration on product characteristics in the process of research and development, scored tablets should be developed in accordance with clinical needs, and specification description should be standardized for clarifying the clinical use of the scored tablets.
关键词
刻痕片 /
分剂量 /
临床使用 /
技术要求
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Key words
scored tablet /
tablet splitting /
clinical use /
technical requirement
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中图分类号：
R944
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参考文献
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