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根据FDA和CFDA口服固体制剂溶出度试验技术指导原则的要求,为防止仿制药一致性评价过程中相似因子(f2)法的滥用和不恰当应用,采用样本数据实例演示的方式说明多变量置信区间法和模型依赖法作为补充手段在溶出曲线相似性比较和BE风险预评估中的重要性。
According to FDA and CFDA oral solid preparation dissolution testing guidelines, in order to prevent abuse and improper application of similar factor (f2) in the process of generic drug consistency assessment, the sample data is used to illustrate the multivariate confidence interval The importance of the law and model-dependent approach as a complement to comparisons of stripping curve similarity and BE risk pre-assessment.