摘要
美国食品药品管理局(FDA)于2018年4月发布了"供企业用的严重衰弱或危及生命的血液病:药物非临床研发指导原则"。该指导原则描述了这类药物简化的非临床研究方案,我国目前尚无类似的指导原则。详细介绍该指导原则,以期对我国这类药物非临床研究和评价有帮助。
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.
作者
萧惠来
XIAO Huilai(Center for Drug Evaluation,State Drug Administration,Beijing 100022,China)
出处
《药物评价研究》
CAS
2019年第3期422-426,共5页
Drug Evaluation Research