Phase 3 Study means a clinical study of a drug candidate in patients that incorporates accepted endpoints for confirmation of statistical significance of efficacy and safety in order to obtain Regulatory Approval in any country, as further described in 21 C.F.R. 312.21(c) with respect to the United States, 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
A Randomized, Double-Blind, Placebo-Controlled, Parallel- Group, Multicenter Phase 3 Study to Investigate the Efficacy and Safety of FInerenone, in Addition to Standard of Care, on the Progression of Kidney Disease in Patients With Non-Diabetic Chronic Kidney Disease.
Exploratory Analyses From Apollo-B, A Phase 3 Study Of Patisiran In Patients With Attr Amyloidosis With Cardiomyopathy.
Novartis shall have the right to determine whether it is willing to Manufacture Regional Antibody Candidates and Regional Licensed Products for use in Commercialization of such Regional Antibody Candidates and Regional Licensed Products in the Surface Territory and shall communicate such determination by written notice to Surface no later than Initiation of the first Phase 3 Study.
The QAPP, entitled Building Demolition Evaluation Phase 3 Study of the Alternative Asbestos Control Method, was QA-approved on 12/05/07.
If Xxxxxxx xr any of its Affiliates intends to conduct a first Phase 3 Study of a Licensed Product, then, following completion of Xxxxxxx’x internal approvals to conduct such Phase 3 Study, Xxxxxxx xill notify Licensor in writing of Xxxxxxx or its Affiliate’s intent to conduct such Phase 3 Study.
More Definitions of Phase 3 Study
Phase 3 Study means, wherever in the world conducted, a study in humans of the safety and efficacy of a product, which is prospectively designed to demonstrate statistically whether such product is safe and effective for use in the indication under investigation in a manner sufficient to file to obtain BLA approval to market and sell that product in the U.S. or any other country for the indication under investigation in such study or that would otherwise satisfy the requirements of 21 C.F.R. § 312.21(c) in the U.S., or its foreign equivalent.
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 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 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 Clinical Study of an investigational product in subjects that incorporates accepted endpoints for confirmation of statistical significance of efficacy and safety with the aim to generate data and results that can be submitted to obtain Regulatory Approval 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.
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.