[關(guān)鍵詞]
[摘要]
藥物安全性預(yù)測(cè)聯(lián)盟(PSTC)集合眾多制藥企業(yè)的力量,在美國(guó)食品藥品監(jiān)督局(FDA)和歐洲醫(yī)藥評(píng)價(jià)署(EMEA)的指導(dǎo)下致力于藥物安全性監(jiān)測(cè)的研究,并向FDA和EMEA呈交了7種腎損傷生物標(biāo)志物的研究結(jié)果。目前,F(xiàn)DA和EMEA評(píng)估并接受了這7種新的生物標(biāo)志物,使之用于檢測(cè)尿中反映腎損傷的信號(hào)。這些新的檢測(cè)指標(biāo)現(xiàn)在可作為藥物評(píng)價(jià)的一部分,用于實(shí)驗(yàn)室探索實(shí)驗(yàn)性藥物的安全性,從而使藥物在安全性上更加可靠。
[Key word]
[Abstract]
The Predictive Safety Testing Consortium (PSTC) brings pharmaceutical companies together to share and qualify new and improved safety testing methods with US and European regulatory agencies as advisors. And the seven urinary renal safety biomarkers were submitted to the FDA and EMEA by PSTC. Now FDA and EMEA have reviewed and accepted the seven new biomarkers-laboratory tests on urine that signals kidney injury. These new tests can be used in laboratory research to predict the safety of experimental drugs, enabling drugs to be greater confidence in their safety.
[中圖分類號(hào)]
[基金項(xiàng)目]