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Human Liver Microphysiological System for Assessing Drug-Induced Liver Toxicity In Vitro
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2002年至2024年期间FDA批准的儿科肝功能障碍剂量

Deandra A Cassel1, Gilbert J Burckart1, Martina D Sahre1

  • 1Office of Clinical Pharmacology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.

Clinical pharmacology and therapeutics
|July 25, 2025
PubMed
概括

由于挑战,儿童药物开发很少评估肝功能障碍 (HI) 剂量. 这项研究发现儿科HI剂量建议存在显著差距,现有指导方针的支持证据有限.

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