从研究到开发，候选者过渡过程中人类免疫反应建模方法。
Approaches to modelling the human immune response in transition of candidates from research to development.
机构信息
Defence Science and Technology Laboratory (DSTL), Porton Down, Salisbury, Wilts SP4 0JQ, UK.
出版信息
J Immunol Res. 2014;2014:395302. doi: 10.1155/2014/395302. Epub 2014 May 7.
Abstract
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.
摘要
本综述考虑了在候选生物防御疫苗或疗法从研究阶段出现时，为将其推向开发阶段而需要采取的评估步骤。本文还考虑了在 FDA 的动物规则背景下，对疗效进行临床前建模的选择。
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