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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 (...
| Autores principales: | , , , , , , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
| Publicado: |
Mary Ann Liebert, Inc., publishers
2022
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| Materias: | |
| 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 |