Phase III Clinical. Trial shall mean a pivotal multi-center human clinical trial in a large number of patients to establish safety or efficacy in the particular claim and indication tested and required to obtain Regulatory Approval.
Phase III Clinical. Trial shall mean a clinical trial of a Licensed Product in human patients, which trial is designed (a) to establish that the Licensed Product is safe and efficacious for its intended use, (b) to define warnings, precautions and adverse reactions that are associated with such Licensed Product in the dosage range to be prescribed, (c) to be, either by itself or together with one or more other Clinical Trials having a comparable design and size, the final human Clinical Trial in support of Regulatory Approval of a Marketing Authorization of such Licensed Product, and (d) consistent with 21 U.S. CFR § 312.21(c). [***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and 230.406.
Phase III Clinical. Trial shall mean a clinical study in patients, conducted in accordance with a protocol approved by the Joint Operations Committee, which protocol is designed to ascertain efficacy and safety of a Product for the purpose of preparing and submitting a Registration Filing to the competent Regulatory Authority in a particular country in the Territory.
Examples of Phase III Clinical in a sentence
Current and Future Analysis Targeted Therapy – An OverviewTargeted Therapy: The New Frontier of Cancer Treatment List of Select Approved Targeted Therapy Drugs by IndicationSelect Targeted Anti-Cancer Therapies in Late-Stage (Phase III) Clinical Development Table 7.
For NIH-defined Phase III Clinical Trials: Include a description of the plans for valid analysis in the study design and outcomes.
Note: Phase III Clinical Trials generally require both a DSMB and a Plan.
Subgroup Analyses in Reporting of Phase III Clinical Trials in Solid Tumors.
Non-Exempt Human Subjects ResearchCriteriaHuman Subjects Research YesExemption Claimed NoClinical Trial No NIH-Defined Phase III Clinical Trial NoInstructions and Required Information Although no specific page limitation applies to this section of the application, be succinct.
More Definitions of Phase III Clinical
Phase III Clinical. TRIALS shall have the meaning set forth in Section 6.1(b).
Phase III Clinical. Trial shall mean a controlled, and usually multi-center, clinical trial, involving patients with the disease or condition of interest intended to obtain sufficient efficacy and safety data to support Marketing Approval of a candidate drug whether or not designated as “Phase III”, such as trials referred to in 21 C.F.R. §312.21(c) and foreign equivalents. Typical elements of a Phase III Clinical Trial are described in more detail in Section 3.1.3.3 of ICH Topic E8 (GENERAL CONSIDERATIONS FOR CLINICAL TRIALS).
Phase III Clinical. Trial shall mean one or more controlled studies in humans of the efficacy and safety of an R&D Candidate, which is prospectively designed to demonstrate statistically whether the R&D Candidate is safe and ef- fective for use in a particular indication, in a manner intended to be sufficient to obtain Regulatory Approval to market that R&D Candidate and which the Joint Project Team designates as a Phase III Clinical Trial.
Phase III Clinical. Trial or Pivotal Trial means (a) a controlled study of a Product in patients of the efficacy and safety of such Product which is prospectively designed to demonstrate statistically whether such Product is effective and safe for use in a particular indication in a manner sufficient to obtain Regulatory Approval to market such Product or (b) a clinical trial that the sponsoring Party or its Affiliate refers to in a press release as a Phase III Clinical Trial or Study.
Phase III Clinical. TRIALS means a series of expanded controlled and uncontrolled, pivotal, multi-center (generally) clinical studies, after adequate completion of preliminary efficacy and dose-ranging studies, and after safety data has been established for a PENN LICENSED PRODUCT, comprising patients with the disease or condition of interest, to whom the PENN LICENSED PRODUCT is administered in order to obtain sufficient efficacy and safety data (and better understand drug-related adverse effects) to support regulatory submissions and labeling of the PENN LICENSED PRODUCT.
Phase III Clinical. Trial shall mean a human clinical trial that is prospectively designed to demonstrate statistically whether a product is safe and effective for use in humans in a manner sufficient to obtain regulatory approval to market such product in patients having the disease or condition being studied as described in 21 C.F.R. § 312.21(c) FDCA, as amended from time to time, and the equivalent legislation in the Licensed Territory. For clarity, the PROTECT Study and the DUPLEX Study are each a Phase III Clinical Trial hereunder.
Phase III Clinical. Study shall mean a controlled study to confirm with statistical significance the efficacy and safety of a candidate drug or medical device product performed to obtain marketing and/or manufacturing approval for the product in any country.