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耿颖, 丁锐, 魏宁漪, 张启明, 徐昕怡, 尚悦, 廖萍, 杨泉, 刘嘉楠, 马玲, 陈华

Study on the harmonization of weight (filling) variation test of Chinese Pharmacopoeia with ICH Q4B Annex 6 with respect to the harmonization consideration and statistical simulation

GENG Ying, DING Rui, WEI Ning-yi, ZHANG Qi-ming, XU Xin-yi, SHANG Yue, LIAO Ping, YANG Quan, LIU Jia-nan, MA Ling, CHEN Hua

中国新药杂志 . 2026, (9): 903 -910 . DOI: 10.20251/j.cnki.1003-3734.2026.09.002