本文關(guān)鍵詞： 藥物 臨床試用 臨床試驗(yàn) 全面質(zhì)量管理 監(jiān)管模式　出處：《中國(guó)新藥與臨床雜志》2015年12期 　論文類型：期刊論文

【摘要】：臨床試驗(yàn)是藥物上市審批前的必經(jīng)環(huán)節(jié)和重要依據(jù)。本院已建立了一套規(guī)范的藥物臨床試驗(yàn)質(zhì)量監(jiān)管模式,即加強(qiáng)藥物臨床試驗(yàn)機(jī)構(gòu)、各專業(yè)組、倫理委員會(huì)三個(gè)環(huán)節(jié)對(duì)臨床試驗(yàn)的全過程監(jiān)督管理。本文在總結(jié)本院藥物臨床試驗(yàn)質(zhì)量監(jiān)管過程中的經(jīng)驗(yàn)和問題的基礎(chǔ)上,建議完善醫(yī)院藥物臨床試驗(yàn)的管理體系,提高藥物臨床試驗(yàn)質(zhì)量,以促使本院的藥物臨床試驗(yàn)質(zhì)量管理模式達(dá)到國(guó)際化先進(jìn)水平。
[Abstract]:Clinical trial is the necessary link and important basis before the examination and approval of drug listing. Our hospital has established a set of standardized quality supervision model of drug clinical trial, that is, strengthen the drug clinical trial organization, each specialized group. On the basis of summarizing the experience and problems in the process of quality supervision of clinical trials in our hospital, the three links of ethics committee supervise and manage the whole process of clinical trials. It is suggested that the management system of clinical trials of drugs in hospitals should be perfected and the quality of clinical trials of drugs should be improved so as to promote the quality management mode of clinical trials of drugs in our hospital to reach the international advanced level.
【作者單位】： 陜西中醫(yī)學(xué)院;中國(guó)人民解放軍第四軍醫(yī)大學(xué)西京醫(yī)院藥劑科;
【基金】：國(guó)家自然科學(xué)基金(81302627,81302695)
【分類號(hào)】：R95
【正文快照】： 藥物臨床試驗(yàn)是評(píng)價(jià)藥物干預(yù)人體后的安全性和有效性,以及人體對(duì)藥物的吸收、分布、代謝與排泄的規(guī)律,為是否批準(zhǔn)藥物上市提供依據(jù),為上市后臨床合理用藥提供支撐[1]。近年來,為了保證臨床試驗(yàn)過程規(guī)范、結(jié)果科學(xué)可靠、保護(hù)受試者的權(quán)益,我國(guó)藥物臨床試驗(yàn)機(jī)構(gòu)(以下簡(jiǎn)稱“機(jī)構(gòu)，

本文編號(hào)：1470074