Common Problems and Concerns in the Bioequivalence Trial of Semi-Solid Formulations for Topical Skin Application
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.
semi-solid formulations for topical skin applicationbioequivalence trialquality control system
万方数据
维普
