Bridging Animal and Human Data in Pursuit of Vaccine Licensure

The FDA Animal Rule was devised to facilitate approval of candidate vaccines and therapeutics using animal survival data when human efficacy studies are not practical or ethical. This regulatory pathway is critical for candidates against pathogens with high case fatality rates that prohibit human ch...

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Detalles Bibliográficos
Autores principales: Finch, Courtney L., Dowling, William E., King, Thomas H., Martinez, Christian, Nguyen, Bai V., Roozendaal, Ramon, Rustomjee, Roxana, Skiadopoulos, Mario H., Vert-Wong, Ekaterina, Yellowlees, Ann, Sullivan, Nancy J.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2022
Materias:
Review
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9503666/
https://www.ncbi.nlm.nih.gov/pubmed/36146462
http://dx.doi.org/10.3390/vaccines10091384

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9503666/
https://www.ncbi.nlm.nih.gov/pubmed/36146462
http://dx.doi.org/10.3390/vaccines10091384

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