本文關(guān)鍵詞： 藥物 臨床試用 臨床試驗 全面質(zhì)量管理 監(jiān)管模式　出處：《中國新藥與臨床雜志》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)范的藥物臨床試驗質(zhì)量監(jiān)管模式,即加強藥物臨床試驗機構(gòu)、各專業(yè)組、倫理委員會三個環(huán)節(jié)對臨床試驗的全過程監(jiān)督管理。本文在總結(jié)本院藥物臨床試驗質(zhì)量監(jiān)管過程中的經(jīng)驗和問題的基礎(chǔ)上,建議完善醫(yī)院藥物臨床試驗的管理體系,提高藥物臨床試驗質(zhì)量,以促使本院的藥物臨床試驗質(zhì)量管理模式達到國際化先進水平。
[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)學院;中國人民解放軍第四軍醫(yī)大學西京醫(yī)院藥劑科;
【基金】：國家自然科學基金(81302627,81302695)
【分類號】：R95
【正文快照】： 藥物臨床試驗是評價藥物干預人體后的安全性和有效性,以及人體對藥物的吸收、分布、代謝與排泄的規(guī)律,為是否批準藥物上市提供依據(jù),為上市后臨床合理用藥提供支撐[1]。近年來,為了保證臨床試驗過程規(guī)范、結(jié)果科學可靠、保護受試者的權(quán)益,我國藥物臨床試驗機構(gòu)(以下簡稱“機構(gòu)，

本文編號：1470074