美國食品藥品管理局（FDA）于2018年4月發(fā)布了"供企業(yè)用的嚴(yán)重衰弱或危及生命的血液?。核幬锓桥R床研發(fā)指導(dǎo)原則"。該指導(dǎo)原則描述了這類藥物簡化的非臨床研究方案，我國目前尚無類似的指導(dǎo)原則。詳細(xì)介紹該指導(dǎo)原則，以期對我國這類藥物非臨床研究和評價有幫助。

FDA issued "Severely Debilitating or Life-Threatening Hematologic Disorders:Nonclinical Development of Pharmaceuticals Guidance for Industry" in April 2018.The guideline described a streamlined nonclinical study program of these drugs.At present,there is no similar guidance in our country.This article introduces the guidance in detail and expects to be helpful for the non-clinical study and evaluation of these drugs in China.