{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,17]],"date-time":"2026-10-17T03:42:25Z","timestamp":1792208545246,"version":"4.4.0"},"reference-count":52,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2026,10,2]],"date-time":"2026-10-02T00:00:00Z","timestamp":1790899200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"},{"start":{"date-parts":[[2026,10,2]],"date-time":"2026-10-02T00:00:00Z","timestamp":1790899200000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["ascpt.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clin Pharma and Therapeutics"],"published-print":{"date-parts":[[2026,11]]},"abstract":"<jats:p>Pediatric developmental safety assessment presents distinct challenges in drug development. Children undergo dynamic changes in organ systems and drug disposition pathways during development, and drug\u2010related effects may be delayed or manifested differently than in adults. Pharmacovigilance data, primarily from adults, is not always predictive of the response in children. Historically, juvenile animal studies have been used for nonclinical pediatric drug safety assessments exclusively, but the reduction in animal testing is a goal of public health agencies. To address this concern, the Office of Clinical Pharmacology at the U.S. FDA and the Triangle CERSI (Center of Excellence in Regulatory Science and Innovation) convened a workshop entitled: \u201cPediatric Developmental Safety Assessment and New Approach Methodologies (NAMs),\u201d attended by experts from regulatory agencies, academia, and industry. 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