Objective To reduce the unnecessary bias in the bioequivalence(BE)trial of semi-solid formulations for topical skin application,and to promote the trial process more standardized and rigorous.Methods The relevant literature on the requirements of semi-solid formulations for topical skin application in the BE trial was reviewed,and the possible problems that might occur during the trial protocol review period,initiation period,trial period,and trial end period based on the trial experience of the trial center were summarized,and corresponding quality control measures were put forward.Results and Conclusion Attention should be paid to the precautions of drug preservation,administration process,and subject management.Quality control or drills should be carried out at key points where problems are prone to occur,which can help researchers complete the BE trial of semi-solid formulations for topical skin application more standardized and rigorous.
关键词
皮肤外用半固体制剂/生物等效性试验/质量控制体系
Key words
semi-solid formulations for topical skin application/bioequivalence trial/quality control system
维普
万方数据