Dose escalation studies nonrodents

Dose escalation studies in rodent and nonrodent These studies are generally the first time the test article is administered to a living system. They provide an initial indication of toxicity, organs involved, and doses that can be used in longer term studies. Many times these studies are not conducted in full compliance with GLPs. 

Such studies provide important information for a better interpretation of the toxicity observed in animals, and aid in the selection of not only the proposed initial human dose but of the dose-escalation scheme and the frequency of dosing in the clinical trial(s). Further, once such exposure data are available in humans, the data can be used to better correlate the human and animal findings. Toxicity studies should be performed in the same species used to assess exposure. Often, exposure and toxicity are measured in the same study, particularly when nonrodents are used. 

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