FDA和EMEA批准7种肾损伤生物标志物正式使用

药物安全性预测联盟（PSTC）集合众多制药企业的力量,在美国食品药品监督局（FDA）和欧洲医药评价署（EMEA）的指导下致力于药物安全性监测的研究,并向FDA和EMEA呈交了7种肾损伤生物标志物的研究结果。目前,FDA和EMEA评估并接受了这7种新的生物标志物,使之用于检测尿中反映肾损伤的信号。这些新的检测指标现在可作为药物评价的一部分,用于实验室探索实验性药物的安全性,从而使药物在安全性上更加可靠。

Official use of seven new biomarkers of renal injury approved by FDA and EMEA

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.