从美国FDA完全回应函看化药药学审评:关键缺陷与评价考量
任峰, 程思绮, 姜涛, 陈爱萍, 汤志全, 张景辰
From FDA Complete Response Letters on the pharmaceutical assessment of chemical drugs: critical deficiencies and review considerations
REN Feng, CHENG Si-qi, JIANG Tao, CHEN Ai-ping, TANG Zhi-quan, ZHANG Jing-chen
中国新药杂志
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2025, (23): 2490
-2496
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DOI: 10.20251/j.cnki.1003-3734.2025.23.005