儿科药物发育安全性评估的次级药理学靶点：临床药理学考量
Secondary Pharmacology Targets for Pediatric Developmental Safety Assessment of New Drugs: Clinical Pharmacology Considerations
作者：Gilbert J. Burckart、Sherbet Samuels、Susan M. Abdel‐Rahman、Gelareh Abulwerdi、Elimika Fletcher、Mohamed A. Mohamoud、Apoorva Srinivasan、Nicholas Tatonetti、Rebecca Racz
单位：Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.；Office of Pediatric Therapeutics, Office of the Commissioner, US Food and Drug Administration, Silver Spring, Maryland, USA.；Department of Computational Biomedicine, Cedars-Sinai Medical Center, West Hollywood, California, USA.
摘要
《Clinical Pharmacology & Therapeutics》发表述评，系统探讨新药儿科开发中次级药理学靶点在发育安全性评估中的作用。文章从临床药理学视角分析如何识别和评估非预期靶点介导的儿童发育毒性，为儿科药物安全评价提供方法论参考。
AI 主编 · 推荐理由推荐理由
药企儿科研发和药物安全评价团队应将次级药理学评估纳入儿科发育毒性研究的常规策略，在早期非临床阶段即开展靶点选择性分析，可降低后期临床风险。