[關(guān)鍵詞]
[摘要]
非臨床研究質(zhì)量管理規(guī)范(good laboratory practice for nonclinical study,GLP)是藥物非臨床安全性評價研究機構(gòu)必須遵循的規(guī)范,與藥物毒理學(xué)有著密切的聯(lián)系。藥物毒理學(xué)研究促進了GLP的發(fā)生與發(fā)展;同時,GLP要求實驗管理做到規(guī)范化和標準化,保障了藥物非臨床安全性評價研究的科學(xué)性與可靠性,加快了我國藥物毒理學(xué)研究與國際接軌?,F(xiàn)就GLP與藥物毒理學(xué)的關(guān)系進行簡要的論述。
[Key word]
[Abstract]
Good laboratory practice (GLP) for nonclinical study is a norm that must be followed by non-clinical drug safety evaluation agencies, and has a close relationship with drug toxicology. Drug toxicology promotes the occurrence and development of GLP. At the same time, GLP requires laboratory management to be normalized and standardized, which ensures the scientificity and reliability of nonclinical safety evaluation, and accelerates the internationalization of drug toxicology. In this paper, the relationship between GLP and drug toxicology is discussed.
[中圖分類號]
[基金項目]