中国药典生物检定统计实例不同计算方式结果比较和几点修改建议

目的: 通过比较2010年版中国药典二部附录ⅪV(生物检定统计法)、BS 2000、SAS三者计算的结果，对BS 2000计算软件的有效性进行确认。方法: 将2010年版中国药典二部附录ⅪV生物检定统计法中的实例使用BS 2000、SAS 2种软件分别进行计算，比较二者与中国药典结果的差异。结果和结论: 经确认，BS 2000与SAS软件均可用于中国药典中的生物检定统计。但发现中国药典、BS 2000、SAS所得结果，包括所得效价(P_T)、可信限(FL)、可信限率(FL%)、标准误(S_M)均存在不同程度的差异，对差异产生的原因进行分析并提出修改意见。

Objective: To validate the efficacy of the bioassay calculation software—BS 2000 through comparing the bioassay results given in the appendix ⅪV of Chinese pharmacopeia(ChP)Ⅱ(2010)with the results calculated by BS 2000 and SAS procedures. Methods: The raw data presented in appendix ⅪV of ChP Ⅱ were calculated by BS 2000 and SAS procedures respectively,then the obtained results were compared with the results from ChP. Results and Conclusion :The validation showed BS 2000 and SAS procedures could be used for bioassay statistics in ChP.However,there were some differences in the results(e.g.potency of test sample(P_T),fiducial limit(FL),fiducial limit ratio(FL%),standard error(S_M)).Therefore,the reasons of differences were analyzed and some revising suggestions were proposed.

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