Phase III Clinical Trials means a Clinical Trial for the Product on sufficient numbers of patients to generate safety and efficacy data to support Regulatory Approval in the proposed therapeutic indication, conducted in accordance with current good clinical practices and in accordance with a protocol that has been reviewed by the FDA and reflects any comments or concerns raised by the same.
Phase III Clinical Trials means those trials on sufficient numbers of patients that are designed to establish that a drug is safe and efficacious for its intended use, and to define warnings, precautions and adverse reactions that are associated with the drug in the to be prescribed dosage range, and supporting Regulatory Approval of such drug.
Phase III Clinical Trials means investigational use of a Licensed Product for establishing its safety, efficacy, labeled indications, and risk–benefit profile in humans, under 21 C.F.R. Part 312 or comparable laws, rules, or regulations of another Regulatory Authority.
Examples of Phase III Clinical Trials in a sentence
For NIH-defined Phase III Clinical Trials: Include a description of the plans for valid analysis in the study design and outcomes.
Note: Phase III Clinical Trials generally require both a DSMB and a Plan.
Subgroup Analyses in Reporting of Phase III Clinical Trials in Solid Tumors.
Therefore, the respondents of the questionnaires will be from the relevant corporate level experts who are responsible for adopting IFRS or else who are responsible for preparation and edition of financial reports from finance department and the auditors.
NIH-defined Phase III Clinical Trials: Planning, Conducting, and Reporting of Analyses for Sex/Gender and Race/Ethnicity Differences.
More Definitions of Phase III Clinical Trials
Phase III Clinical Trials means a human clinical trial that satisfies the requirements for a Phase III study as defined in 21 C.F.R. 312.21(c) (or its successor regulation).
Phase III Clinical Trials means large scale human clinical ------------- trials conducted in patients to establish product efficacy in the particular indication tested and required to obtain Product registration with health regulatory authorities.
Phase III Clinical Trials means that portion of the Development Program that provides for human clinical studies in the Field that (a) are conducted in a number of patients that is intended to be sufficient to obtain a definitive evaluation of the therapeutic efficacy and safety of a Product in patients for a given Indication as required by 21 C.F.R. §312.21(c), and (b) are needed to evaluate the overall risk-benefit relationship of the Product and to provide adequate basis for obtaining requisite Regulatory Approvals.
Phase III Clinical Trials means clinical trials designed to demonstrate safety and efficacy of a compound proposed to be used as a therapeutic pharmaceutical product in an expanded patient population at geographically dispersed study sites, meeting the requirements established by the FDA for Phase III clinical trials. A Phase III Clinical Trial is deemed to commence upon acceptance of a trial protocol with the FDA and concludes with the filing of an NDA with the FDA.
Phase III Clinical Trials means a clinical trial identified as a Phase III clinical trial in the Development Plan and conducted as a pivotal trial for purposes of filing a MAA for a Product that provides for the clinical study of such Product on a sufficient number of patients to confirm with statistical significance the efficacy, and confirm the safety of such Product, sufficient to support such MAA for such Product.
Phase III Clinical Trials has the meaning ascribed thereto in 21 C.F.R. Section 312.21(c), as amended from time to time.
Phase III Clinical Trials means clinical trials designed to demonstrate safety and efficacy of a compound proposed to be used as a prophylactic, therapeutic or diagnostic pharmaceutical product in an expanded patient population at geographically dispersed study sites, meeting the requirements established by the U.S. Food and Drug Administration for Phase III clinical trials.