Refers to a "test" drug produced by a drug discovery program from which data is collected and evaluated to demonstrate that the drug is safe and effective. Prior to commencing clinical trials (which must be performed on human subjects), an Investigational New Drug Application must be filed with the FDA. The IND application must contain information that will demonstrate the safety of testing in human subjects, including drug composition, manufacturing and control data, results of testing on animals, training and experience of investigators and a plan for clinical investigation. In addition, assurance of informed consent and protection of the rights and safety of human subjects is required.
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