Phase 1 Clinical Trial

Phase 1 Clinical Trial. Means a human clinical trial of a Product, the principal purpose of which is to evaluate safety in healthy individuals or patients, to determine pharmacokinetic parameters and other key pharmaceutical properties of such Product (including absorption, metabolism, and elimination), or to determine the appropriate range of doses to evaluate in further clinical trials, in each case as described in 21 C.F.R. § 312.21(a), or a similar clinical study prescribed by the Regulatory Authorities in a... country other than the United States View More

Phase 1 Clinical Trial. A Clinical Trial that is designed in a manner that is generally consistent with 21 CFR § 312.21(a)

Phase 1 Clinical Trial. A clinical trial, the principal purpose of which is preliminary determination of safety of a Licensed Product in healthy individuals or patients and that otherwise satisfies the description in 21 C.F.R. §312.21(a) in the United States or, if applicable, its foreign equivalent.