Phase III Clinical Trial definition

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 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 an NDA or would otherwise satisfy requirements of 21 CFR 312.21(c), or its foreign equivalent.

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

• 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.

• Scenario C: Human Subjects Research Claiming Exemption 1, 2, 3, 4, 5, or 6 CriteriaHuman Subjects Research YesExemption Claimed 1, 2, 3, 4, 5, or 6Clinical Trial Yes or NoNIH-Defined Phase III Clinical Trial No Instructions and Required InformationAlthough no specific page limitation applies to this section of the application, be succinct.

• Internal document: Phase III Clinical Trial (CL010_168) (submitted as part of the application for marketing authorization approval) Jayne D.R.W. et al.: N Engl J Med.

• These studies are designed to monitor effectiveness of the approved intervention in the general population and to collect information about any adverse effects associated with widespread use.NIH-Defined Phase III Clinical Trial.

• Specifically we regress the log of number of securities granted during the year on the dummy variable Phase III Clinical Trial Failure.

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 human clinical trial of a Product, conducted in a manor generally consistent with US regulation 21 CFR § 312.21(c), as amended (or its successor regulation), or other comparable regulation imposed by a Regulatory Agency in any country of the Territory.

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 pivotal clinical trial with a defined dose or a set of defined doses of a pharmaceutical product designed to ascertain efficacy and safety of such product, in a manner that is generally consistent with 21 CFR § 312.21(c), as amended (or its successor regulation), or that satisfies the requirements of similar laws or regulations outside the United States.

Phase III Clinical Trial a large scale, pivotal, multi-centre, human clinical trial to be conducted in a number of patients estimated to be sufficient to primarily establish efficacy of a Product in the medical indication being investigated and at a standard suitable to obtain Marketing Authorisation in the Territory (excluding dose ranging studies).

Phase III Clinical Trial means a Clinical Trial, a purpose of which is to obtain, after preliminary evidence suggesting effectiveness of a pharmaceutical product has been obtained, additional information about the safety and efficacy of a pharmaceutical product that is needed to evaluate the overall benefit-risk relationship of the pharmaceutical product and to provide an adequate basis for seeking regulatory approval to market such product for patients with the disease or condition under study, as further described in 21 CFR § 312.21(c) or foreign counterpart thereto, or a similar Clinical Trial in a country other than the United States.