Phase I Study definition

Phase I Study means a study in humans which provides for the first introduction into humans of a product, conducted in healthy volunteers or patients to obtain information on product safety, tolerability, pharmacological activity or pharmacokinetics, as more fully defined in 21 C.F.R. § 312.21(a) (or the non-United States equivalent thereof).

Phase I Study means a human clinical trial in any country that would satisfy the requirements of 21 C.F.R. § 312.21(a) (FDCA), as amended from time to time, and the foreign equivalent thereof.

Phase I Study means a clinical study of the Licensed Product in human volunteers or patients the purpose of which is preliminary determination of safety and tolerability of an escalating dose regime and for which the primary endpoints in the protocol relate to safety.

Examples of Phase I Study in a sentence

• SCE has now performed the QC12 Phase I Study for the Generating Facility, and this report addresses the results of the analysis.

• Identification of facility voltages (220 kV) in this Phase I Study are shown consistent with SCE System Operating Bulletin 123.

• More specifically, the key criteria applicable to this Phase I Study are as follows:• The thermal rating of any conductor, connector, or apparatus shall not exceed 100% of its normal rated capacity with all facilities in service (N-0 or base case).

• Notwithstanding the terms of Section 3.6(b), all Manufacturing Costs necessary to produce Product in sufficient volumes and quality necessary for conduct of the first Phase I Study of the first Product in the Field will be borne [*] percent ([*]%) by Alexion and [*] percent ([*]%) by XOMA.

• REPORT OBJECTIVESCE performed a QC14 Phase I Study that included the Generating Facility, and this report addresses the results of the analysis.

More Definitions of Phase I Study

Phase I Study means a human clinical trial in any country or region that would satisfy the requirements of 21 C.F.R. 312.21(a) or the counterpart in such country or region, but which is not a Phase II Study, Phase III Study or Phase IV Study.

Phase I Study means a human clinical trial of a compound or product, the principal purpose of which is to establish an initial safety profile and to determine the metabolism, pharmacokinetics, pharmacodynamics and pharmacologic actions of the compound or product in humans, the side effects associated with increasing doses and, if possible, to gain early evidence of effectiveness, as more fully defined in 21 C.F.R. § 312.21(a), or its foreign equivalent.

Phase I Study means a Phase I clinical trial as prescribed by applicable FDA regulations, or corresponding regulations of any comparable entity.

Phase I Study means a clinical study in subjects to evaluate the pharmacokinetic and pharmacodynamic properties, maximum tolerated dose, dosing interval, and absorption, distribution, metabolism and excretion (ADME) of a candidate drug.

Phase I Study. As defined in Section 5.2.

Phase I Study means any study in healthy humans to obtain initial data regarding the safety and pharmacokinetics of a product

Phase I Study means: (a) that portion of the FDA submission and approval process which provides for the first introduction into humans of a product with the purpose of determining human toxicity, metabolism, absorption, elimination and other pharmacological action, as more fully defined by the rules and regulations of the FDA, including 21 C.F.R. § 312.21(a) or any future revisions or substitutes therefor; or (b) a similar clinical trial in any national jurisdiction other than the United States. For the avoidance of doubt, the emphasis of a PHASE I STUDY is on the safety and tolerability of a product and is used to plan patient dosing in a PHASE II STUDY.