四参数模型在生物效价计算中的注意事项

Some attention issues in potency calculating using 4-parameter model

通过调研目前国内法规和使用四参数模型计算效价的实验室数据,对生物效价测定在使用四参数模型计算中常见问题总结如下:(1)《中华人民共和国药典》虽然收载了多个品种的四参数模型计算要求,但对使用该模型进行效价计算时缺乏具体要求。(2)国内实验室在使用该模型计算生物效价时,在实验设计、系统适用性和样本适用性等方面均存在评价不足,没有提供充分的数据分析及结果,从而导致结果的可信程度下降。(3)由于差异性检验的自身缺陷,建议今后使用该模型时,对样品适用性的统计检验逐步过渡到使用等效性检验,以保证计算的准确性和科学性。

After investigating the current domestic regulations and the original data calculation using four-parameter model from labs,some common problems were summarized as follows：（1）Although some kinds of products＇ s monographes have been included in Pharmacopoeia of the People＇s Republic of China（Ch P）which uses four parameter model for potency calculation,the monograph in Ch P lacks specific requirements for the calculation.（2）There were some insufficiency assessment in experiment design,system suitability and sample suitability in some domestic labs when using the model to calculate,which led to the decrease of the credibility of the results.（3）Owing to the disadvantages of difference test,it suggested that the statistical test should be gradually transitioned to the equivalent test for assessment of the suitability of the sample to promote the accuracy and scientificity of the calculation,when the model was used for calculation of potency.