Phase 3 Study means a clinical study of a drug candidate in human patients that incorporates accepted endpoints for confirmation of statistical significance of efficacy and safety with the aim to obtain Regulatory Approval in any country as described in 21 C.F.R. 312.21(c), or a comparable clinical study prescribed by the relevant Regulatory Authority in a country other than the United States. The relevant drug candidate may be administered to patients as a single agent or in combination with other investigational or marketed agents.
Phase 3 Study means a human clinical trial of a Licensed Product in any country, the primary purpose of which is to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the Licensed Product and to provide an adequate basis for physician labeling, as more fully defined in 21 C.F.R. §312.21(c) or its successor regulation, or the equivalent in any foreign country.
Phase 3 Study means a human clinical trial of a compound or product for an Indication on a sufficient number of subjects that is designed to establish that the compound or product is safe and efficacious for its intended use, and to determine warnings, precautions, and adverse reactions that are associated with the compound or product in the dosage range to be prescribed, and to support Regulatory Approval of the compound or product for such Indication or label expansion of the compound or product.
Examples of Phase 3 Study in a sentence
The Pop PK analyses relied on pooled sparse teprotumumab PK data from 84 patients enrolled in two aforementioned clinical studies in TED patients (Phase 2 Study TED01RV and Phase 3 Study HZNP-TEP-301) and intensive PK data from 36 patients with advanced solid tumors, non- Hodgkin’s lymphoma, or Hodgkin’s lymphoma enrolled in the Phase 1 Study BO19373.
Phase 3 Study Design in AD RUN - IN Double Blind Treatment Period Long - term Safety Extension Treatment Period (Open Label) 12 Weeks 7 Days Up to 52 Weeks Topline Results: 1H2025 est.
IN Efficacy Assessment Treatment Period (Double Blind) Long - term Safety Extension Treatment Period (Double Blind) KICK 1 & KICK 2: Phase 3 Study Design in CKD KICK1 US sites only, KICK 2 US and ex - US sites Patients Re - Randomized to DFK or PBO RANDOMIZE (N = ~400; 1:1) Placebo QD DFK 1.0 mg QD Placebo QD DFK 1.0 mg QD Topline Results: 2H2024 est.
Control of Toxic Chemicals in Puget Sound, Phase 3: Study of Atmospheric Deposition of Air Toxics to the Surface of Puget Sound.
Pfizer and BioNTech Announce Vaccine Candidate Against COVID-19 Achieved Success in First Interim Analysis from Phase 3 Study.
More Definitions of Phase 3 Study
Phase 3 Study means a human clinical trial of a compound or product for an indication on a sufficient number of subjects that is designed to establish that such compound or product is safe and efficacious for its intended use, and to determine warnings, precautions and adverse reactions that are associated with the compound or product in the dosage range to be prescribed, and to support regulatory approval of such compound or product for such indication or label expansion of such compound or product.
Phase 3 Study means a pivotal human clinical trial in any country the results of which could be used to establish safety and efficacy of a PRODUCT IN CLASS as a basis for a marketing application that would satisfy the requirements of 21 CFR 312.21(c) or other comparable regulation imposed by the FDA or its foreign counterpart.
Phase 3 Study means a human Clinical Trial conducted in any country in the Licensed Territory on Licensed Product that meets the requirements of 21 CFR §312.21(c), and that, when the results of such trial are combined with the clinical data from other Clinical Trials on Licensed Product completed as of the Completion of such trial, are intended (by sponsor thereof) to be sufficient to be able to prepare and file an NDA with the FDA covering Licensed Product. A Phase 3 Study typically is a large scale clinical study (usually several hundreds of patients) performed after preliminary evidence suggesting effectiveness of the drug has been obtained in phase 2 clinical studies, and it is intended to gather the pivotal information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug and, along with other Clinical Trials, to provide an adequate basis for Regulatory Approval.
Phase 3 Study has the meaning set forth in Paragraph 1.6 (Schedule A).
Phase 3 Study means a controlled study in humans of the efficacy and safety of a 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 file an NDA to obtain Regulatory Approval to market the product, as further defined in 21 C.F.R. § 312.2l(c) (or the non-United States equivalent thereof).
Phase 3 Study means a Clinical Study of a Licensed Product as a monotherapy or in combination with one or more other products: (a) on a sufficient number of patients, which trial (i) is designed to establish that such Licensed Product is safe and efficacious for its intended use and (ii) is pivotal to support Marketing Approval for such Licensed Product; or (b) that meets the definition in 21 C.F.R. §312.21(c) or any of its foreign equivalents.
Phase 3 Study means a clinical study of an investigational product in patients the protocol of which incorporates accepted endpoints for confirmation of statistical significance of efficacy and safety with the aim of obtaining Regulatory Approval in any country as described in 21 C.F.R. § 312.21(c), or a comparable clinical study prescribed by the relevant Regulatory Authority in a country other than the United States. The investigational product can be administered to patients as a single agent or in combination with other investigational or marketed agents and shall be deemed commenced when the first patient in such study has received his or her initial dose of a product. For clarity, Phase 3 Studies include clinical studies of approved products for use in Indications for which such product has not yet received Regulatory Approval.