Phase III definition

Phase III means Phase I (or Phase I/II), Phase II (or Phase II/III) and Phase III clinical trials, respectively, in each case as prescribed by applicable FDA IND Regulations, or any corresponding foreign statutes, rules or regulations.

Phase III means human clinical trials, the principal purpose of which is to establish substantial evidence of both safety and efficacy in patients with the disease or condition being studied, as more fully defined in 21 C.F.R. §312.21(c) or similar clinical study in a country other than the United States. Phase III shall also include any other human clinical trial intended to serve as a pivotal trial to support the submission of an application for regulatory approval.

Phase III means a human clinical trial of a Licensed Product, which trial is designed to: (a) establish that a 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) support regulatory approval of such Licensed Product; and (d) be generally consistent with 21 CFR § 312.21(c). Said trial may be conducted in any country.

Examples of Phase III in a sentence

• Project Cost Estimating and BWCC Support will be utilized during Phase II to compile the re-estimate of the Phase III portion of the project.

• These Guidelines apply to injury caused to patients involved in Phase II and Phase III trials, that is to say, patients under treatment and surveillance (usually in hospital) and suffering from the ailment which the medicinal product under trial is intended to treat but for which a product licence does not exist or does not authorise supply for administration under the conditions of the trial.

• The expanded rights would be extinguished should the Recipient achieve financial close and take the Project into Phase III.

• The Recipient agrees that it will be required in Phase III to “true-up” (i.e., repay DOE if the project terminates during Phase III an amount sufficient to ensure that the non-federal cost-share for Phase III is not less than 55.5 percent).

• The MedUni Wien is the legal sponsor of the study "A Randomized, Double-Blind, Placebo- Controlled, Parallel Group, Multi-center, Phase III Study to Evaluate the Efficacy and Safety of Baricitinib as a Remission-Induction and Glucocorticoid-Sparing Regimen in Subjects with New-Onset Polymyalgia Rheumatica (JAK-SPARE 1)" ("Study"), protocol I4V-NS-0015 ("Protocol") regarding bariticinib and placebo ("Study Drug").

More Definitions of Phase III

Phase III means that portion of the clinical development program which provides for the pivotal trials of a product in sufficient numbers of patients to establish the safety and efficacy of a product for the desired label claims and indications.

Phase III means the third phase of human clinical trials of a drug required by the US FDA to gain evidence of efficacy in the target population, and obtain expanded evidence of safety for Product(s), as described in 21 CFR Part 312, as it may be amended.

Phase III in reference to a clinical trial means a trial defined in 21 C.F.R. 312.21(c), as may be amended from time to time, or any foreign equivalent thereto.

Phase III means Phase I, Phase II and Phase III clinical trials, respectively, in each case as prescribed by the U.S. Food and Drug Administration or a corresponding foreign entity.

Phase III means Phase I (or Phase I/II), Phase II, and Phase III clinical trials, respectively, in each case as prescribed by the regulations of the applicable government agency or other regulatory entity.

Phase III means Phase III clinical trials as prescribed by applicable FDA regulations, regardless of whether such trials are conducted in the United States or elsewhere.

Phase III means a human clinical trial, the principal purpose of which is to establish safety and efficacy of the Product in patients with the disease being studied, as further described in 21 C.F.R. §312.21(c) (including, any such clinical study in any country other than the United States), which is designed and intended to be of a size and statistical power sufficient to serve as a pivotal study to support the filing of an MAA for the indication being studied.