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中国生物类似药研发与评价技术指导原则评析
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作者: Shein-chung Chow1, Fu-yu Song2, Laszlo Endrenyi3 作者(英文):Shein-chung Chow1, Fu-yu Song2, Laszlo Endrenyi3 单位:1. Duke University School of Medicine, Durham, North Carolina, USA; 2. Peking University Clinical Research Institute, Beijing 100191, China; 3. University of Toronto, Toronto, Canada 单位(英文):1. Duke University School of Medicine, Durham, North Carolina, USA; 2. Peking University Clinical Research Institute, Beijing 100191, China; 3. University of Toronto, Toronto, Canada 关键词:生物相似性;批内变异;批间变异;非劣效试验;高变异性药物 关键词(英文):biological similarity; within-batch variability; between-batch variability; non-inferiority trials; highly variable drug |
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