definiens: and ( each a ) shall have the following meanings : ( a ) shall mean a study in humans which provides for the first introduction into humans of aproduct, conducted in normal volunteers or patients to get information on product safety, tolerability, pharmacologicalactivity or pharmacokinetics, as more fully defined in Federal Regulation 21 C.F.R. § 312.21(a ) ; ( b ) shall mean a study in humans of the safety, dose ranging and efficacy of a product, whichis prospectively designed to generate sufficient data ( if successful ) to commence Phase III clinical trials, as furtherdefined in Federal Regulation 21 C.F.R. § 312.21(b ) ; ( c ) shall mean a controlled and lawful study in humans of the efficacy and safety of a product, which is prospectively designed to demonstrate statistically whether such product is effective and safe for use in aparticular indication in a manner sufficient to file an NDA to obtain regulatory approval to market the product, asfurther defined in Federal Regulation 21 C.F.R. § 312.21(c )