ANIMAL MODELS OF HUMAN VIRAL INFECTIONS FOR EVALUATION OF EXPERIMENTAL THERAPIE

用于评估实验疗法的人类感染动物模型合同提供了一种或多种具有良好特征的人类病毒性疾病病毒-动物模型，用于评估候选抗病毒疗法的实验使用。对于所有模型，感染过程和/或疾病发病机制应尽可能与相应的人类疾病相似。对治疗剂进行毒性和疗效评价。适当时，进行免疫学、病毒学、病理学和毒理学试验，以监测试验剂对受感染动物的影响，并进行研究，以评估药物递送和给药的新策略，包括联合和顺序给药。这些研究应包括适当的未感染和未治疗的对照。

The Animal Models of Human Infections for Evaluation of Experimental Therapies contract provides one or more well-characterized virus-animal model(s) of a human viral disease for experimental use for evaluation of candidate antiviral therapies. For all models, the process of infection and/or disease pathogenesis should resemble the corresponding human disease as closely as possible. The therapeutic agents shall be evaluated for toxicity and efficacy. When appropriate, conduct immunologic, virologic, pathologic, and toxicologic tests to monitor the effects of the test agent on the infected animals, and conduct studies to evaluate novel strategies for drug delivery and dosing, including combination and sequential drug administration. These studies shall include appropriate uninfected and untreated controls.