1 what was the rule of the animals ?
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1: There is a reasonably well-understood mechanism for the toxicity of the agent and its amelioration or prevention by the product; 2: The effect is demonstrated in either: 2.1: More than one animal species expected to react with a response predictive for humans; or.
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The FDA animal efficacy rule (also known as animal rule) applies to development and testing of drugs and biologicals to reduce or prevent serious/life-threatening conditions caused by exposure to lethal or permanently disabling toxic agents (chemical, biological, radiological, or nuclear substances), where human
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