Regulatory Consideration for the Nonclinical Safety Assessment of Gene Therapies-Reference-Cited by-同舟云学术

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Regulatory Consideration for the Nonclinical Safety Assessment of Gene Therapies

Published:2022-09-14 Issue: Volume: Page:
ISSN:1043-0342
Container-title:Human Gene Therapy
language:en
Short-container-title:Human Gene Therapy

Author:

Moffit Jeffrey S.¹^ORCID,Blanset Diann L.²,Lynch Jessica L.³,MacLachlan Timothy K.⁴,Meyer Kathleen E.⁵,Ponce Rafael⁶,Whiteley Laurence O.⁷

Affiliation:

1. Carbon Biosciences, Lexington, Massachusetts, USA.

2. Boehringer Ingelheim, Ridgefield, Connecticut, USA.

3. Janssen Research and Development, Spring House, Pennsylvania, USA.

4. Novartis Institutes for Biomedical Research, Cambridge, Massachusetts, USA.

5. Sangamo Therapeutics, Inc., Richmond, California, USA.

6. Shape Therapeutics, Seattle, Washington, USA.

7. Pfizer, Cambridge, Massachusetts, USA.

Publisher

Mary Ann Liebert Inc

Subject

Genetics,Molecular Biology,Molecular Medicine

Link

https://www.liebertpub.com/doi/pdf/10.1089/hum.2022.090

Reference48 articles.

1. Nonclinical Studies that Support Viral Vector-Delivered Gene Therapies: An EFPIA Gene Therapy Working Group Perspective

2. Current progress and limitations of AAV mediated delivery of protein therapeutic genes and the importance of developing quantitative pharmacokinetic/pharmacodynamic (PK/PD) models

3. Systemic and local immune responses to intraocular AAV vector administration in non-human primates

4. Optimising the IgG‐degrading enzyme treatment regimen for enhanced adeno‐associated virus transduction in the presence of neutralising antibodies

5. Impact of Pre-Existing Immunity on Gene Transfer to Nonhuman Primate Liver with Adeno-Associated Virus 8 Vectors

Cited by 3 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. Development of Cell and Gene Therapies for Clinical Use in the US and EU: Summary of Regulatory Guidelines;Current Gene Therapy;2025-02

2. Navigating the Genetic Landscape: A Comprehensive Review of Novel Therapeutic Strategies for Retinitis Pigmentosa Management;Cureus;2024-08-16

3. Technological advancements in viral vector designing and optimization for therapeutic applications;Advances in Protein Chemistry and Structural Biology;2024

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