普通口服固体制剂溶出度试验技术指导原则(国家食品药品监管总局通告2015年第3号) ... ...

2023-4-6 12:45| 发布者: 享瑾美| 查看: 713| 评论: 0|来自: 国家药监局

摘要: 本则适用于普通口服固体制剂,包括:1)溶出度试验的一般要求;2)根据生物药剂学特性建立溶出度标准的方法;3)溶出曲线比较的统计学方法;4)体内生物等效性试验豁免(即采用体外溶出度试验代替体内生物等效性试验 ...


参考文献

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