皮肤外用半固体制剂生物等效性试验的常见问题与关注点

Common Problems and Concerns in the Bioequivalence Trial of Semi-Solid Formulations for Topical Skin Application

目的减少皮肤外用半固体制剂在生物等效性(BE)试验中不必要的偏差,使试验过程更规范、严谨。方法查阅相关文献中皮肤外用半固体制剂在BE试验中的要求,并结合试验中心的试验经验,总结BE试验在试验方案审核期、启动期、试验期、试验结束期可能产生的问题,并提出相应的质量控制措施。结果与结论应重点关注药物储存、给药过程及受试者管理的注意事项,在易产生问题的关键节点做好质量控制或演练,能帮助研究者更规范、严谨地完成皮肤外用半固体制剂的BE试验。

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.