摘要
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。结果与结论: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。
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 )(IV 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 Condusion: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 ( PT ), fiducial limit ( FL), fiducial limit ratio( FL% ), standard error( SM ) ). Therefore, the reasons of differences were analyzed and some revising sug- gestions were proposed.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2013年第11期1858-1861,共4页
Chinese Journal of Pharmaceutical Analysis
基金
中检院学科带头人基金项目:统计学分析方法在药品检定中的应用研究(课题编号2011X3)