Regulatory Consideration for the Nonclinical Safety Assessment of Gene Therapies

The nonclinical safety assessments for gene therapies are evolving, leveraging over 20 years of experimental and clinical experience. Despite the growing experience with these therapeutics, there are no approved harmonized global regulatory documents for developing gene therapies with only the ICH (...

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Detalles Bibliográficos
Autores principales: Moffit, Jeffrey S., Blanset, Diann L., Lynch, Jessica L., MacLachlan, Timothy K., Meyer, Kathleen E., Ponce, Rafael, Whiteley, Laurence O.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Mary Ann Liebert, Inc., publishers 2022
Materias:
Reviews
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9700330/
https://www.ncbi.nlm.nih.gov/pubmed/35994386
http://dx.doi.org/10.1089/hum.2022.090

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9700330/
https://www.ncbi.nlm.nih.gov/pubmed/35994386
http://dx.doi.org/10.1089/hum.2022.090

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