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(ChP)which uses four parameter model for potency calculation,the monograph in ChP 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.
[1] SCHWARZ TF,SPACZYNSKI M,SCHNEIDER A,et al.Immunogenicity and tolerability of an HPV-16/18 AS04-adjuvanted prophylactic cervical cancer vaccine in women aged 15-55 years[J].Vaccine,2009,27(4):581
[2] COUCH RB,DECKER WK,UTAMA B,,et al.Evaluations for in vitro correlates of immunogenicity of inactivated influenza A H5,H7 and H9 vaccines in humans[J].PLoS One,2012,7(12):e50830
[3] CUMBERLAND WN,FONG Y,YU X,et al.Nonlinear calibration model choice between the four and five parameter logistic models[J].J Biopharm Stat,2015,25(5):972
[4] Molecular Devices Corporation.Softmax Pro User's Manual[EB/OL].[2017-10-15].http://www.docin.com/p-241442998.html
[5] LEE J,BOTTJE WG,KONG BW.Genome-wide host responses against infectious laryngotracheitis virus vaccine infection in chicken embryo lung cells[J].BMC Genomics,2012,24(13):143
[6] USP 40-NF 35[S].2017:General Information<1032>.Design and development of biological assay
[7] USP 40-NF 35[S].2017:General Chapter<111>.Design and analysis of biological assay
[8] USP in Process Revision<1210>.Statistical Tools for Procedure Validation[J/OL].Pharmacopeial Forum 2014,40(5)[2017-10-15].http://www.usppf.com/pf/pub/index.html
[9] 谭德讲,冯国双,朱容蝶,等.一致性评价所用统计分析方法辨析[J].中国新药杂志,2017,26(24):2881 TAN DJ,FENG GS,ZHU RD,et al.Analysis of the meanings of equivalence and the required statistical evaluation methods[J].Chin J New Drugs,2017,26(24):2881
[10] YANG H,KIM HJ,ZHANG L,et al.Implementation of parallelism testing for four-parameter logistic model in bioassays[J].PDA J Pharm Sci Technol,2012,66(3):262
[11] 冯国双,朱容蝶,谭德讲,等.药品检验中等效区间的确定方法与应用[J].中华医学杂志,2017,97(48):3835 FENG GS,ZHU RD,TAN DJ,et al.The determination of equivalence limits and application in pharmaceuticals assays[J].Natl Med J China,2017,97(48):3835
[12] CARDOT JM,DAVIT BM.In vitro-in vivo correlations:tricks and traps[J].AAPS J,2012,14(3):491
