Phase III Clinical Study definition

Phase III Clinical Study. Phase III Clinical Study means a human clinical study to confirm with statistical significance the efficacy and safety of Licensed Product performed to obtain Regulatory Approval for Licensed Product in any country, which shall be deemed commenced when the third patient in such study has received his or her initial dose of Licensed Product.

Phase III Clinical Study means a trial involving administration of a Compound to sufficient numbers of human patients with the goal of establishing that the Compound is safe and efficacious for its intended use, to define warnings, precautions and adverse reactions that are associated with the drug or label expansion of such Compound, and to be considered as a pivotal study for submission of an NDA.

Phase III Clinical Study means a study in human patients with a defined dose or a set of defined doses of a Product which study, if the defined end-points are met, is designed to ascertain or establish efficacy and safety of such Product in patients for the indication being studied for the purpose of preparing and submitting a Regulatory Approval Application to the competent Regulatory Authority in a country of the world.

Examples of Phase III Clinical Study in a sentence

• Licensee will notify GenuPro in writing upon its first initiation of a Phase III Clinical Study in the Field involving a CTM Product within fourteen (14) days of such initiation.

• Phase III Clinical Study shall also include any other human clinical trial serving as a pivotal study from which the data are actually submitted to the applicable Regulatory Authority in connection with a Regulatory Marketing Approval Application, whether or not such trial is called a “Phase III” study.

• Telix shall make a one-time payment to Wilex of US$[**] within [**] after enrollment of the last patient in a Phase III Clinical Study using a Diagnostic Product.

• The applicable Participating Phase IIb Party’s JDC representatives shall have the right to determine whether such Product Candidate is ready to be Developed in a Phase III Clinical Study or whether one or more additional Clinical Studies or Non-Clinical Studies should be conducted prior to Development in a Phase III Clinical Study.

• For each Product Candidate, promptly after completion of all Development activities under the applicable Joint Phase IIb Plan, the applicable JDC shall evaluate all results pertaining to such Product Candidate and determine whether such Product Candidate is ready to be Developed in a Phase III Clinical Study or whether one or more additional Clinical Studies or Non-Clinical Studies should be conducted prior to Development in a Phase III Clinical Study.

More Definitions of Phase III Clinical Study

Phase III Clinical Study means a human clinical trial that would satisfy the requirements of 21 C.F.R. 312.21(c) in the United States, or a similar clinical study prescribed by the relevant governmental authority in a country other than the United States.

Phase III Clinical Study means a clinical trial involving administration of the Compound to sufficient numbers of human patients with the goal of establishing that the Compound is safe and efficacious for its intended use, to define warnings, precautions and adverse reactions that are associated with the drug or label expansion of the Compound, and to be considered as a pivotal study for submission of an NDA; and generally consistent with 21 CFR §312.21(b), or its foreign equivalent in non-U.S. countries of the Territory. A Phase III Clinical Study can comprise a Phase IIIa clinical study and a Phase IIIIb clinical study. A Phase IIIb clinical study is performed to further define findings found in a Phase IIIa clinical study.

Phase III Clinical Study means, as to a particular Licensed Product, a clinical study in humans that is prospectively designed to assess the safety and effectiveness of such Licensed Product in a manner sufficient to file a Drug Approval Application for the Indication under investigation in the study. Without limiting the generality of the foregoing, a clinical study shall be deemed to be a “Phase III Clinical Study” hereunder if such study has been designated by the sponsor as a Phase III clinical trial on xxx.xxxxxxxxxxxxxx.xxx (or any successor website maintained by the U.S. National Institutes of Health (or any successor agency of the U.S. Government)).

Phase III Clinical Study means any pivotal Clinical Trial(s), which Clinical Trial(s) is(are) designed to (a) establish that the Licensed Product is safe and efficacious for its intended use; (b) define warnings, precautions and adverse reactions that are associated with the Licensed Product in the dosage range to be prescribed; (c) be a pivotal study for submission of an Regulatory Approval Application to obtain regulatory approval for such Licensed Product in any region or regulatory jurisdiction, as defined in 21 C.F.R. § 312.21(c), as may be amended from time to time, or any analogous clinical trial described or defined in Applicable Laws.

Phase III Clinical Study means a Product Study with study design and statistical power intended to meet the requirement for Approval by the FDA.

Phase III Clinical Study means a human clinical trial of a Licensed Compound or Product on a sufficient number of subjects in an indicated patient population that is designed to establish that a Licensed Compound or Product is safe and efficacious for its intended use and to determine the benefit/risk relationship, warnings, precautions and adverse reactions that are associated with such product in the dosage range to be prescribed, which trial is intended to support marketing approval of such Licensed Compound or Product, including all tests and studies that are required by the FDA from time to time, pursuant to applicable Law or otherwise, including the trials referred to in 21 C.F.R. §312.21(c), as amended.

Phase III Clinical Study means a study of a Licensed Product in human patients with a defined dose or a set of defined doses of a Licensed Product designed to (a) ascertain efficacy and safety of such Licensed Product for its intended use; (b) define warnings, precautions and adverse reactions that are associated with the Licensed Product in the dosage range to be prescribed; and (c) support preparing and submitting applications for Regulatory Marketing Approval to the competent Regulatory Authorities in a country of the world, as and to the extent defined for the United States in 21 C.F.R.§ 312.21(c), or its successor regulation, or the equivalent regulation in any other country. Phase III Clinical Study shall also include any other human clinical trial serving as a pivotal study from which the data are actually submitted to the applicable Regulatory Authority in connection with a Regulatory Marketing Approval Application, whether or not such trial is called a “Phase III” study.