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Approaches to Modelling the Human Immune Response in Transition of Candidates from Research to Development

This review considers the steps required to evaluate a candidate biodefense vaccine or therapy as it emerges from the research phase, in order to transition it to development. The options for preclinical modelling of efficacy are considered in the context of the FDA's Animal Rule.

Detalles Bibliográficos
Autor principal: Williamson, Diane
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Hindawi Publishing Corporation 2014
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4033477/
https://www.ncbi.nlm.nih.gov/pubmed/24949489
http://dx.doi.org/10.1155/2014/395302