Initial Proof of Principle

In most cases, a proof of principle (i.e. initial indication of clinical efficacy) during early Phase II clinical studies will require clinical treatment for some period of time, ranging from days (diagnostic agents, etc.) to weeks or months (for other types of drug). Since exposure of patients in clinical trials (in most cases) cannot last beyond the duration of the animal studies, careful consideration of the development schedule must be made, so that no delays are caused through lack of toxicological coverage. This requires that the appropriate pre-clinical reports are available prior to the planned initiation of the clinical trial.

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