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美国食品药品监督管理局(FDA)于2015年6月发布了《药物雄性介导发育毒性风险评估指导原则》(草案),阐述了当前FDA对男性人群使用药物后产生的潜在相关发育毒性风险评估的策略与方法,拓展了对传统雄性生殖与发育毒性的认识与评价。该指导原则对于指导研究者进行药物临床和非临床雄性生殖与发育毒性评价具有重要意义,而我国目前对此类毒性风险尚未特殊关注。简介该指导原则主要内容,以供研究者参考。
In June 2015, the United States Food and Drug Administration (FDA) released the Draft Guiding Principles for Assessment of Male-Mediated Developmental Toxicity in Drugs (Draft), describing the current risk assessment of the potential associated developmental toxicity of the FDA when administered to the male population Strategies and methods to expand awareness and evaluation of traditional male reproductive and developmental toxicity. This guideline is of great significance for guiding researchers to evaluate the toxicity of clinical and non-clinical male reproductive and developmental drugs, but our country does not pay special attention to this kind of toxicity risk at present. Brief introduction of the main content of the guideline, for researchers reference.