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Updated: Jun 25, 2025

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关于在欧盟确定狭窄治疗指数药物的生物等价性的双向建议

Paulo Paixao1,2, Alfredo Garcia Arieta2,3, Nuno Silva1

  • 1Research Institute for Medicines (iMed.ULisboa), Faculty of Pharmacy, University of Lisbon, 1649-004 Lisboa, Portugal.

Pharmaceutics
|May 25, 2024
PubMed
概括

一种新的混合方法简化了对狭窄治疗指数 (NTI) 药物的生物等价性 (BE) 的证明. 这种方法可以减少临床试验的样本大小,而不会增加假阳性结果的风险,有利于药物开发.

关键词:
生物等价性 生物等价性仿制药是指一般的药物.药品监管 药品监管 药品监管 药品监管狭窄的治疗指数药物药物.

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