title: Approaches to modelling the human immune response in transition of candidates from research to development.
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.
authors.affiliation: Defence Science and Technology Laboratory (DSTL), Porton Down, Salisbury, Wilts SP4 0JQ, UK.
authors.forename: Diane
authors.initials: D
authors.lastname: Williamson
mesh_terms: D056704:Adaptive Immunity / Q000187:drug effects; D000827:Animal Welfare / Q000941:ethics / Q000331:legislation & jurisprudence; D000818:Animals; D001424:Bacterial Infections / Q000276:immunology / Q000382:microbiology / Q000517:prevention & control*; D001428:Bacterial Vaccines / Q000008:administration & dosage / Q000276:immunology*; D004195:Disease Models, Animal; D006801:Humans; D057170:Translational Research, Biomedical / Q000941:ethics / Q000458:organization & administration*; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D001428:Bacterial Vaccines