通過(guò)查閱相關(guān)文獻(xiàn)并結(jié)合筆者實(shí)踐經(jīng)驗(yàn)，基于FMECA、問(wèn)卷調(diào)查法，從“試驗(yàn)藥物管理、生物檢測(cè)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(gè)層面列出了61個(gè)生物等效性試驗(yàn)臨床實(shí)施階段的失效模式，完成調(diào)查問(wèn)卷的設(shè)計(jì)和發(fā)放。針對(duì)問(wèn)卷結(jié)果運(yùn)用SPSS 25.0軟件計(jì)算出了各故障失效模式下對(duì)應(yīng)的風(fēng)險(xiǎn)優(yōu)先系數(shù)值，并按照從大到小的順序進(jìn)行風(fēng)險(xiǎn)排序。對(duì)處于較高風(fēng)險(xiǎn)以上的失效模式進(jìn)行原因分析并針對(duì)性提出了預(yù)防規(guī)避措施，有利于促進(jìn)我國(guó)藥物生物等效性試驗(yàn)更加科學(xué)和規(guī)范的開(kāi)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(jì)劃資助研究課題（201803010036）