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粉液双室袋产品无菌工艺模拟试验设计考量及监管检查关注点探析
张然, 胡小娟, 朱倩倩, 叶六平, 胡士高
中国药事 ›› 2026, Vol. 40 ›› Issue (9) : 1071-1080.
PDF(1351 KB)
PDF(1351 KB)
粉液双室袋产品无菌工艺模拟试验设计考量及监管检查关注点探析
({{custom_author.role_cn}}), {{javascript:window.custom_author_cn_index++;}}Design Considerations and Analysis of Regulatory Inspection Focus Points for Aseptic Process Simulation Tests of Powder-Liquid Dual-Chamber Bag Products
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