A roadmap towards a human-centric safety assessment of advanced therapy medicinal products.

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第一作者： Hsiao-Tzu,Chien

第一单位： Medicines Evaluation Board, Utrecht, the Netherlands; Radboud University Medical Center, Nijmegen, the Netherlands. Electronic address: h.chien@cbg-meb.nl.

作者： Hsiao-Tzu,Chien ^[1] ; Victoria C,de Leeuw ^[2] ; Joantine C J,van Esterik ^[2] ; Frans G M,Russel ^[3] ; Anne S,Kienhuis ^[2] ; Peter T,Theunissen ^[3] ; Peter,van Meer ^[3]

作者单位： Medicines Evaluation Board, Utrecht, the Netherlands; Radboud University Medical Center, Nijmegen, the Netherlands. Electronic address: h.chien@cbg-meb.nl. ^[1] Centre for Health Protection, National Institute for Public Health and the Environment, Bilthoven, the Netherlands. ^[2] Medicines Evaluation Board, Utrecht, the Netherlands; Radboud University Medical Center, Nijmegen, the Netherlands. ^[3]

关键词 3Rs Advanced therapy medicinal products In vivo studies New approach methodologies Nonclinical Regulatory

主题词人类(Humans);动物(Animals);危险性评估(Risk Assessment);药物评价, 临床前(Drug Evaluation, Preclinical)

DOI 10.1016/j.yrtph.2024.105631

PMID 38648873

发布时间 2024-06-10

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准确一般字义偏差语意偏离译文作用小提交