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Exploratory clinical studies, as defined in the ICH M3R2 Guideline, are those intended to be conducted early in Phase I, involve limited human exposure, have no therapeutic intent, and are not intended to examine clinical tolerability. Exploratory approaches for first-in-human studies have been developed in order to drive the selection of compounds or targeted drug approaches based on human data rather than solely animal and in vitro data.

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Q: What is exploratory clinical trial?
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