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.
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1989 ◽
Vol 21
(4)
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pp. 386???392
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2004 ◽
Vol 227
(4)
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pp. 463-486
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2005 ◽
Vol 11
(37)
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pp. 5777
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1997 ◽
Vol 65
(7)
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pp. 2668-2675
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