目的:汇总体外透皮试验(In Vitro Permeation Test,IVPT)的设计要求和评价方法,并以Excel中函数公式计算IVPT,助力评价皮肤局部外用制剂仿制药研发质量与疗效.方法:对比美国食品药品管理局(Food and Drug Administration,FDA)、欧洲药品管理局(European Medicines Agency,EMA)、日本医药品医疗器械综合机构(Pharmaceuticals and Medical Devices Agency,PMDA)及国家药品监督管理局(National Medical Products Administration,NMPA)相关指导原则中IVPT设计要求及评价方法,并以Excel软件中函数公式计算IVPT,与SAS软件计算结果进行比较.结果:相比于EMA和PMDA对皮肤局部外用制剂仿制药IVPT的评价标准,FDA的评价标准更适合我们对仿制药IVPT进行评价,也较容易被我国药监部门所接受.体外透皮试验除皮肤膜选择PMDA推荐的大鼠、小鼠或猪等至少任何一种动物的腹部或背部外,其他设计可参考FDA指导原则相关建议.对于IVPT结果,Execl软件函数公式计算结果与SAS软件计算结果一致.结论:可优先采用FDA的皮肤局部外用制剂仿制药IVPT指导原则设计试验,并以其评价标准进行等效性评价.此外,本研究已验证Excel替代SAS软件准确计算IVPT,可用于判断皮肤局部外用制剂仿制药研发质量及生物等效性.
Evaluation of in Vitro Permeation Test of Skin Topical Preparations
Objective:To define the design requirements and evaluation methods of in vitro permeation test(IVPT),and calculate the IVPT with the function formula in Excel to evaluate the research and development quality and efficacy of generic drugs for topical skin preparation.Methods:The design requirements and evaluation methods of IVPT in FDA,EMA,PMDA and NMPA are compared.The IVPT is calculated by function formula in Excel,and compared with the results calculated by SAS.Results:Compared with EMA and PM-DA evaluation standards for IVPT of generic drugs for skin topical preparations,FDA evaluation standards are more suitable for us to eval-uate IVPT of generic drugs,and are also more easily accepted by Chinese drug regulatory authorities.For the in vitro permeation test,ex-cept for the abdomen or back of at least any animal such as rats,mice or pigs recommended by PMDA for the skin membrane,other de-signs can refer to the relevant recommendations of FDA guidelines.For the IVPT results,the calculation results of Execl function formula are consistent with those of the SAS.Conclusion:We can give priority to the FDA's guiding principle of generic drug IVPT for topical skin preparation,and evaluate the equivalence with its evaluation criteria.In addition,we have verified that Excel can replace SAS software to accurately calculate IVPT,which can be used to judge the research and development quality and bioequivalence of generic drugs for topi-cal skin preparations.
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