Importance of conducting preclinical study

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Explain in detail the importance of conducting preclinical study early on in the development that will benefits sponsor to assess as to whether the product is reasonably safe for initial testing in humans.

Explain in details the major elements (i.e. study design, dosing regimen etc.) to be included in the clinical protocol that FDA require in order to review the IND application by FDA reviewers.

Reference no: EM133374382

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