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Testing of Adenoviral Vector Gene Transfer Products: FDA Expectations
This chapter describes the agency requirements and guidelines for drug development of adenoviral-containing products. The Food and Drug Administration (FDA) assessment of safety and ultimately effectiveness of adenovirus containing products involves thorough evaluation of the information contained i...
| Autores principales: | , , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
| Publicado: |
2002
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| Materias: | |
| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7155433/ http://dx.doi.org/10.1016/B978-012199504-1/50022-5 |