Phase III Clinical Trial means a pivotal human clinical trial in any country the results of which could be used to establish safety and efficacy of a Product as a basis for a marketing application that would satisfy the requirements of 21 CFR 312.21(c).
Phase III Clinical Trial means a large, controlled or uncontrolled Clinical Study that would satisfy the requirements of 21 CFR 312.21(c), intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling.
Phase III Clinical Trial 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 for Marketing Authorization, or otherwise consistent with the requirements of U.S. 21 C.F.R. §312.21(c) or its foreign equivalents.
Examples of Phase III Clinical Trial in a sentence
Licensee shall (i) file an IND for a Product on or before twenty four (24) months from the Effective Date; and (ii) complete a randomized Phase II Clinical Trial or a Phase III Clinical Trial by the sixth (6th) anniversary of the Effective Date.
More Definitions of Phase III Clinical Trial
Phase III Clinical Trial means a human clinical trial in any country that would satisfy the requirements of 21 CFR 312.21(c).
Phase III Clinical Trial means one or more clinical trials on sufficient numbers of patients, which trial(s) are designed to (a) establish that a drug is safe and efficacious for its intended use; (b) define warnings, precautions and adverse reactions that are associated with the drug in the dosage range to be prescribed; and (c) support Regulatory Approval of such drug, as required by 21 C.F.R. 312(c) or a similar study in other countries.
Phase III Clinical Trial means a clinical trial as defined in 21 C.F.R. 312.21(c), as may be amended from time to time, or any foreign equivalent thereto.
Phase III Clinical Trial means a human clinical trial of the safety and efficacy of a product that is prospectively designed, statistically powered and conducted to provide an adequate basis for obtaining regulatory approval to market such product in the disease being studied, as further described in 21 C.F.R. §312.21(c), or similar clinical study prescribed by the regulatory authorities in a country other than the United States. A Phase III Clinical Trial shall be deemed to have initiated when the first patient in the study has been dosed.
Phase III Clinical Trial means a human clinical trial of a product in any country that would satisfy the requirements of U.S. 21 C.F.R. Part 312.21(c) and is intended to (a) establish that the product is safe and efficacious for its intended use, (b) define contraindications, warnings, precautions and adverse reactions that are associated with the product in the dosage range to be prescribed, and (c) support Regulatory Approval for such product, or a similar clinical study prescribed by the relevant Regulatory Authorities in a country other than the United States.
Phase III Clinical Trial means, as to a particular Product for any Indication, a Clinical Trial in any country that would satisfy the US requirements of 21 CFR 312.21(c) or counterpart rules in other jurisdictions.
Phase III Clinical Trial means one of a series of clinical trials of a Development Compound by administration of such Development Compound to human subjects where the principal purpose of such trial is to provide confirmatory safety and efficacy data primarily to support an application for Regulatory Approval of a Product.