Regulatory Consideration for the Nonclinical Safety Assessment of Gene Therapies.

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第一作者： Jeffrey S,Moffit

第一单位： Carbon Biosciences, Lexington, Massachusetts, USA.

作者： Jeffrey S,Moffit ^[1] ; Diann L,Blanset ^[2] ; Jessica L,Lynch ^[3] ; Timothy K,MacLachlan ^[4] ; Kathleen E,Meyer ^[5] ; Rafael,Ponce ^[6] ; Laurence O,Whiteley ^[7]

作者单位： Carbon Biosciences, Lexington, Massachusetts, USA. ^[1] Boehringer Ingelheim, Ridgefield, Connecticut, USA. ^[2] Janssen Research and Development, Spring House, Pennsylvania, USA. ^[3] Novartis Institutes for Biomedical Research, Cambridge, Massachusetts, USA. ^[4] Sangamo Therapeutics, Inc., Richmond, California, USA. ^[5] Shape Therapeutics, Seattle, Washington, USA. ^[6] Pfizer, Cambridge, Massachusetts, USA. ^[7]

关键词 ICH gene therapy nonclinical regulatory safety toxicity

主题词人类(Humans);动物(Animals);儿童(Child);组织分布(Tissue Distribution)

DOI 10.1089/hum.2022.090

PMID 35994386

发布时间 2024-09-08

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