关键词: font-size:medium, ">皮肤局部外用制剂；体外透皮试验；Excel软件；生物等效性；评价方法

Abstract: 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 PMDA evaluation standards for IVPT of generic drugs for skin topical preparations， FDA evaluation standards are more suitable for us to evaluate IVPT of generic drugs， and are also more easily accepted by Chinese drug regulatory authorities. For the in vitro permeation test， except for the abdomen or back of at least any animal such as rats， mice or pigs recommended by PMDA for the skin membrane， other designs 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 topical skin preparations.

Key words: font-size:medium, ">Topical skin preparation；In vitro permeation test；Excel software；Bioequivalence；Evaluation methods