相对效价测定中不同四参数回归计算法的比较
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- 英文论文题名：Comparison ofdifferent four-parameter regression calculation methods for relative potency
- 论文作者：段徐华 ; 董闪闪 ; 吴利红 ; 邵泓 ; 陈钢
- 英文论文作者：XuhuaDuan ; Shanshan Dong ; Lihong Wu ; Hong Shao ; Gang Chen ; Shanghai Institute for Food and Drug Control
- 年：2016
- 作者机构：上海市食品药品检验所;
- 论文关键词：相对效价 ; 四参数回归 ; 平行性检验 ; 等反应剂量比值
- 英文论文关键词：Relative potency ; Four-parameter regression ; Parallelism assessment ; Constant reaction ratio
- 会议召开时间：2016-09-27
- 会议录名称：中国药学会第十三届青年药学科研成果交流会论文集
- 语种：中文
- 分类号：R392-33
- 学会代码：YYWS
- 会议名称：中国药学会第十三届青年药学科研成果交流会
- 会议地点：中国江西南昌
- 主办单位：中国药学会
- 学会名称：中国药学会
- 页数：6
- 文件大小：653k
- 原文格式：O
- 会议级别：全国
摘要
目的:比较不同质量标准中相对效价测定的四参数回归计算法,考量不同计算方法的科学性和合理性。方法:选取同一批供试品相对效价测定时标准品和供试品的剂量-反应曲线平行性好和平行性不好的数据各一套,对现行版中国药典和国家药品注册标准中收载的用于相对效价测定的四参数回归计算法进行比较。结果:当标准品和供试品的剂量-反应曲线平行性好时,以不同计算方法计算得到的供试品相对效价均很接近,反之结果差异较大,甚至根据某些计算方法应判定为无效数据,不能出具报告。结论:对标准品和供试应品的剂量-反应曲线进行平行性判定是测定供试品相对效价的前提,在平行性成立的条件下,再按等反应剂量比值原则计算供试品相对效价是更为科学合理的计算方法。
Objective:To compare four-parameter regression calculation methodsfor relative potency from different quality standards and study the scientific rationality of different calculation methods.Methods:To choose two set of good and bad data fromparallel does-response curves whichmeasured from same batch of standard and test sample,then calculate and compare according tothe four-parameter regression calculation method from current version of the Chinese Pharmacopoeia and the National Drug Registration Standards.Results:When theparallelism of standard and the test sample does-response curves is good,the relative potencycalculated from different calculation methods are very close,otherwise the results are quite different.Some datamay be invalid in accordance with some calculation method and couldn't be issued a report.Conclusion:The Parallelism assessmentof standard and the test sample does-response curves is the premise of the determination of relative potency of test samples.Under the conditions of established parallelism,calculatingrelative potency of test samplesaccording to the principle constant reaction ratiois more scientific and rational.
Objective:To compare four-parameter regression calculation methodsfor relative potency from different quality standards and study the scientific rationality of different calculation methods.Methods:To choose two set of good and bad data fromparallel does-response curves whichmeasured from same batch of standard and test sample,then calculate and compare according tothe four-parameter regression calculation method from current version of the Chinese Pharmacopoeia and the National Drug Registration Standards.Results:When theparallelism of standard and the test sample does-response curves is good,the relative potencycalculated from different calculation methods are very close,otherwise the results are quite different.Some datamay be invalid in accordance with some calculation method and couldn't be issued a report.Conclusion:The Parallelism assessmentof standard and the test sample does-response curves is the premise of the determination of relative potency of test samples.Under the conditions of established parallelism,calculatingrelative potency of test samplesaccording to the principle constant reaction ratiois more scientific and rational.
引文
1.《中国药典》2015年版三部,通则1431:生物检定统计法,通则195-213
2.周海钧.《药品生物检定》人民卫生出版社,2005,97-115
3.冯国双,谭德讲,刘韫宁,贺庆.四参数log-logistic模型在生物活性测定研究中的应用[J]药物分析杂志2013,33(11).
4.王军志.《生物制品分析方法指导原则》
5.王军志.《生物制品质量控制分析方法验证技术审评一般原则》
6.USP39 chapter<1032>、<1034>
7.EP8.0 chapter 5.3 Statistical analysis of Results of Biological Assays and Tests.
8.BP2016 chapter 5.3 Statistical analysis of Results of Biological Assays and Tests.
2.周海钧.《药品生物检定》人民卫生出版社,2005,97-115
3.冯国双,谭德讲,刘韫宁,贺庆.四参数log-logistic模型在生物活性测定研究中的应用[J]药物分析杂志2013,33(11).
4.王军志.《生物制品分析方法指导原则》
5.王军志.《生物制品质量控制分析方法验证技术审评一般原则》
6.USP39 chapter<1032>、<1034>
7.EP8.0 chapter 5.3 Statistical analysis of Results of Biological Assays and Tests.
8.BP2016 chapter 5.3 Statistical analysis of Results of Biological Assays and Tests.