通過查閱相關(guān)文獻并結(jié)合筆者實踐經(jīng)驗，基于FMECA、問卷調(diào)查法，從“試驗藥物管理、生物檢測樣本管理、研究者依從性、受試者依從性、病房管理、質(zhì)量保證”6個層面列出了61個生物等效性試驗臨床實施階段的失效模式，完成調(diào)查問卷的設計和發(fā)放。針對問卷結(jié)果運用SPSS 25.0軟件計算出了各故障失效模式下對應的風險優(yōu)先系數(shù)值，并按照從大到小的順序進行風險排序。對處于較高風險以上的失效模式進行原因分析并針對性提出了預防規(guī)避措施，有利于促進我國藥物生物等效性試驗更加科學和規(guī)范的開展。

Referred to l relevant literatures as well as personal practices, 61 failure modes were listed based on categories of trial products management, sample testing management, investigators compliance, subjects compliance, ward management, and quality assurance in bioequivalent trials, followed by the design and distribution of a questionnaire. When a critical analysis was conducted to have the risk priority number values for all of the corresponding failure modes were calculated with the SPSS 25.0 software, the risks orders were sorted in the highest to the lowest level. Mitigation strategies suggested to deal with these high-risk failure modes would be conducive to improve quality and standardization of drug bioequivalence trials in China.

R969.1

廣州市民生科技攻關(guān)計劃資助研究課題（201803010036）