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
1National Institutes for Food and Drug Control, Beijing 102629, China
2Ningxia Hui Autonomous Region Institute for Drug Control, Yinchuan 750004, China
3Chinese Pharmacopoeia Commission, Beijing 100061, China
4Shanghai Center of Drug Evaluation and Inspection, Shanghai 201210, China
5China Novartis Institutes for Biomedical Research Co., Ltd., Shanghai 201203, China
6National Health Commission of the People's Republic of China, Beijing 100044, China
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