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Impact of genetically modified organism requirements on gene therapy development in the EU, Japan, and the US
Advanced therapies are emerging as an important class of medicinal products; among these, gene therapies are advancing at an exceptional rate. However, one of the major challenges for gene therapies relates to the additional regulatory requirements for genetically modified organisms. In this paper,...
Autores principales: | Tajima, Gentaro, Huh, Seoan, Schmidt, Natalie Anne, Macdonald, Judith C., Fleischmann, Tobias, Wonnacott, Keith Merrell |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
American Society of Gene & Cell Therapy
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9207611/ https://www.ncbi.nlm.nih.gov/pubmed/35782596 http://dx.doi.org/10.1016/j.omtm.2022.05.012 |
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