FDA/Triangle CERSI工作坊报告：儿科发育安全评估与新研究方法
Pediatric Developmental Safety Assessment and New Approach Methodologies: US FDA/Triangle CERSI Workshop Report
作者：Gilbert J. Burckart、Gelareh Abulwerdi、Christin L. Daniels、Calib Choi、Rebecca Racz、Jean‐Pierre Valentin、Kristin Ardlie、Nicholas Tatonetti、Susan Laffan、Marjory Moreau、Will Redfern、Lang Li、James J. Hickman、Rajanikanth Madabushi、Bhagwat Prasad、Lynne Yao、Paul B. Watkins
单位：Office of Clinical Pharmacology, U.S. FDA, Silver Spring, Maryland, USA.；Triangle Center of Excellence in Regulatory Science and Innovation, Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, Silver Spring, Maryland, USA.；Oak Ridge Institute for Science and Education (ORISE), Oak Ridge, Tennessee, USA.；Early Clinical Development & Translational Science, Non-Clinical Safety Evaluation, Braine L'Alleud, Belgium.；GTEx Laboratory, Data Analysis and Coordination Center, Broad Institute of MIT and Harvard, Cambridge, Massachusetts, USA.；Department of Computational Biomedicine, Cancer Center, Cedars-Sinai Medical Center, Los Angeles, California, USA.；Amgen, Thousand Oaks, California, USA.；ESQlabs, Saterland, Germany.
摘要
美国FDA与Triangle CERSI联合举办工作坊，聚焦儿科药物发育安全性评估及新方法（NAM）的应用。报告总结了当前儿科临床研法挑战、NAM证据整合路径及监管期望，为申办方优化儿科开发策略提供参考。
AI 主编 · 推荐理由推荐理由
提示申办方在儿科药物研发中提前规划NAM证据整合方案，并关注NMPA相关指南跟进。对临床开发团队具有直接指导价值。