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鼻内快速作用药物产品的生物等价性评估

Zhijun Kevin Wang1, Shein Chung Chow2, Moses S S Chow3

  • 1School of Pharmacy and Pharmaceutical Sciences, University of California, Irvine, CA, USA.

Journal of clinical pharmacology
|January 7, 2026
PubMed
概括

确定鼻内药与口服药的生物等价性是一项挑战. 一种具有更广泛的极限和模拟的新型部分AUC方法显示出对评估快速起作用配方的承诺,可能有助于通用药物的批准.

关键词:
生物等价性 生物等价性药物是通过鼻腔内注射的.一部分的AUC.快速起作用的药物批准 快速起作用的药物批准参考尺度 BE 的极限值.瓦尔德纳菲尔 (vardenafil) 是一种药物.

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