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 conducted in accordance with Applicable Laws in any country or countries in subjects with a particular disease or condition the principal purpose of which is to establish safety and efficacy in patients with the disease target being studied as described in or contemplated by 21 C.F.R. §312.21(c), as may be amended from time to time, or other Applicable Laws, that is designed to obtain sufficient data to support the filing of an approvable Drug Approval Application in a Major Market Country.

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, as to the Product, a study in humans performed to gain evidence of the efficacy of such Product in a target population, and to obtain expanded evidence of safety for such Product that is needed to evaluate the overall benefit-risk relationship of such Product and provide an adequate basis for physician labeling, as described in 21 C.F.R. 312.21(c), as amended from time to time, or the corresponding regulation in jurisdictions other than the United States. A Phase III Clinical Trial shall be deemed initiated upon the dosing of the first patient.

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 study in humans, conducted by or on behalf of Licensee, its Affiliate or a sublicensee, of the safety and efficacy of a pharmaceutical product that is prospectively designed, statistically powered and conducted to provide an adequate basis for obtaining Regulatory Approval to market such product for patients with the disease or condition under study, as further described in 21 CFR § 312.21(c) (as may be amended) or foreign counterpart thereto, or a similar clinical study in a country other than the United States.