| FDA治疗严重衰弱或危及生命血液病药物简化的非临床研究指导原则介绍 |
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| 引用本文： | 萧惠来. FDA治疗严重衰弱或危及生命血液病药物简化的非临床研究指导原则介绍[J]. 现代药物与临床, 2019, 42(3): 422-426 |
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| 作者姓名： | 萧惠来 |
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| 作者单位： | 国家药品监督管理局 药品审评中心, 北京 100022 |
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| 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。
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| 关 键 词： | 美国食品药品管理局 严重衰弱或危及生命的血液病 非临床研发 指导原则 |
| 收稿时间： | 2018-11-23 |
Introduction to FDA streamlined nonclinical study guideline for pharmaceuticals used to treat severely debilitating or life-threatening hematologic disorders |
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| XIAO Huilai. Introduction to FDA streamlined nonclinical study guideline for pharmaceuticals used to treat severely debilitating or life-threatening hematologic disorders[J]. Drugs & Clinic, 2019, 42(3): 422-426 |
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| Authors: | XIAO Huilai |
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| Affiliation: | Center for Drug Evaluation, State Drug Administration, Beijing 100022, China |
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| Abstract: | 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. |
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| Keywords: | FDA severely debilitating or life-threatening hematologic disorders nonclinical development guideline |
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