Table 1.
Criteria for use of animal model | Issues relating to smallpox |
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There is reasonably well understood pathophysiological mechanism for the toxicity of the substance and its prevention or substantial reduction by the product. |
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The effect is demonstrated in more than one animal species expected to react with a response predictive for humans, unless the effect is demonstrated in a single animal species that represents a sufficiently well characterized animal model for predicting human response. |
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The animal study endpoint is related clearly to the desired benefit in humans, generally the enhancement of survival or prevention of major morbidity. |
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The data or information on the pharmacokinetics and pharmacodynamics of the product or other relevant data or information, in animals and humans, allow selection of an effective human dose. |
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Adapted from Future Virology (2006) 1(2) 173–179 with permission of Future Medicine Ltd [28].