Phase III Clinical Trial

Example Definitions of "Phase III Clinical Trial"
Phase III Clinical Trial. Any human clinical trial to confirm with statistical significance the efficacy and safety of a Licensed Product, as described under 21 C.F.R. §312.21(c) (as hereafter modified or amended) and any of its foreign equivalents. For avoidance of doubt: any pivotal trial shall be deemed to be a Phase III Clinical Trial
Phase III Clinical Trial. As to a particular product for a particular indication, the large scale human clinical trials conducted in humans of the safety and efficacy of such product for such indication, which is prospectively designed to demonstrate statistically whether such product is safe and effective for use in such indication in order to file an application for regulatory approval with respect to such product for such indication.
Phase III Clinical Trial. The term "Phase III Clinical Trial" shall mean those controlled and lawful studies of a Product conducted anywhere in the Territory on sufficient numbers of patients with the condition treated by the Product that are prospectively designed, using predetermined endpoints, to demonstrate clinically and statistically the efficacy and safety of that Product for one or more indications as a pivotal study intended to lead to regulatory approval of such Product for such indication or indications.
Phase III Clinical Trial. Means a human clinical trial of a Licensed Product that satisfies the requirements of 21 CFR 312.21(c).
Phase III Clinical Trial. A human clinical study on sufficient numbers of patients that is designed to establish that a pharmaceutical product is safe and efficacious for its intended use, and to define warnings, precautions and adverse reactions that are associated with the pharmaceutical product in the dosage range to be prescribed, and to support Regulatory Approval of such pharmaceutical product or label expansion of such pharmaceutical product, as described in 21 C.F.R. § 312.21(c), as amended, or a similar... clinical study prescribed by the Regulatory Authorities in a foreign country View More
Phase III Clinical Trial. The term "Phase III Clinical Trial" means a clinical trial in an extended human patient population designed to obtain data determining efficacy and safety of any Product to support regulatory approvals in the proposed therapeutic indication, as more fully defined in 21 C.F.R. §312.21(c), or its successor regulation, or the equivalent in any foreign country.
Phase III Clinical Trial. As to a particular Licensed Product for a particular indication, a controlled and lawful study in humans of the safety and efficacy of such Licensed Product for such indication, which is prospectively designed to demonstrate statistically whether such Licensed Product is safe and effective for use in such indication in a manner sufficient to file a BLA or New Drug Application or its equivalent to obtain regulatory approval to market and sell that Licensed Product in the United States or any... country for the indication under investigation in such study. View More
Phase III Clinical Trial. Means a pivotal human clinical trial in any country conducted by Company or its Affiliate the results of which could be used to establish safety and efficacy of the Licensed Product as a basis for approval of an NDA for such Licensed Product or that would otherwise satisfy the requirements of 21 CFR 312.21(c) or the equivalent laws, rules or regulations in a regulatory jurisdiction outside the United States.
Phase III Clinical Trial. Means a pivotal human clinical trial of a therapeutic that is designed to ascertain efficacy and safety of such therapeutic for the purpose of enabling the preparation and submission of a regulatory approval application to a competent regulatory authority, as further defined in 21 C.F.R. 312.21(c) for the United States, as amended from time to time, or the corresponding foreign regulations.
Phase III Clinical Trial. As to a specific Licensed Product, a study in humans designed to satisfy the requirements of 21 C.F.R. § 312.21(c), as amended from time to time, or the corresponding regulation in jurisdictions other than the United States. A Phase III Clinical Trial shall be deemed initiated upon the first dosing of the first research subject.
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