Drug Product means a specific drug in dosage form from a known source of manufacture, whether
Drug sample means a unit of a prescription drug that is not intended to be sold and is intended to promote the sale of the drug.
Drug Substance means an active ingredient that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the human body, but does not include intermediates used in the synthesis of such ingredient.
Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).
Finished Product means the final packaged product intended for human consumption;