Human Clinical Trial definition

Human Clinical Trial means any Phase 0 Xxxxx, Xxxxx 0 Xxxxx, Xxxxx 0 Trial or Phase 4 Trial the subject of which includes a Test Product or Product.
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Human Clinical Trial means any clinical program, tested in humans, that has received permission by the United States Food and Drug Administration under an Investigational New Drug pathway.
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Human Clinical Trial means an implant-study in humans which, at the time of commencement of the study, is intended to generate data regarding the safety, efficacy, or both of a Licensed Product to support a regulatory marketing approval application. If Licensed Products are used in “compassionate use” implants, the fiftieth (50th) such implant shall be deemed, for purposes of this Attachment B1, as the commencement of a Human Clinical Trial.
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Examples of Human Clinical Trial in a sentence

  • Price appreciation very quickly reached growth rates not seen since 2004–2005.

  • Human Clinical Trial ContractorHuman clinical trial contractor means a person or organization engaged to provide service, advice or instruction in connection with:A.

  • Evaluation of Stability Changes in Tapered and Parallel Wall Implants: A Human Clinical Trial.

  • The Evolution of a Surgical Robot from Prototype to Human Clinical Trial.

  • A Combination of L-arabinose and Chromium Lowers Circulating Glucose and Insulin Levels After an Acute Oral Sucrose Challenge: A Human Clinical Trial.

  • Present First Human Clinical Trial Data from a ZFP Therapeutic™ We have accomplished a great deal in 2005, and these successes are important steps along the path to achieving our goal of developing ZFP Therapeutics as a new class of drugs.

  • The activation of a Human Clinical Trial grant by the Principal Investigator may be delayed with a full justification submitted in writing.

  • But most independent commercial or academic R&D laboratories do not have access to high quality cGMP CMC facilities to produce clinical grade biologics to help progress their products through Human Clinical Trial.

  • From the transformation of signs derives a sophisticated dynamics defined in terms of a multipronged system, whereby not only the sign and its object considered, but also the Interpretant.

  • Compensation will not be paid for the failure of a Pharmaceutical or Medical Device under Human Clinical Trial to perform its intended purpose.


More Definitions of Human Clinical Trial

Human Clinical Trial means a human clinical trial of a pre-commercial or commercial product.
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Related to Human Clinical Trial

  • Phase 3 Clinical Trial means a pivotal clinical trial in humans performed to gain evidence with statistical significance of the efficacy of a 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, to form the basis for approval of an NDA and to provide an adequate basis for physician labeling, as described in 21 C.F.R. § 312.21(c) or the corresponding regulation in jurisdictions other than the United States.

  • Phase 2 Clinical Trial means a human clinical trial of a product in any country that would satisfy the requirements of 21 C.F.R. 312.21(b) and is intended to explore a variety of doses, dose response, and duration of effect, and to generate initial evidence of clinical safety and activity in a target patient population, or a similar clinical study prescribed by the relevant Regulatory Authorities in a country other than the United States.

  • Phase I Clinical Trial means a human clinical trial that is intended to initially evaluate the safety and/or pharmacological effect of a Product in subjects or that would otherwise satisfy requirements of 21 C.F.R. 312.21(a), or its foreign equivalent.

  • Phase 1 Clinical Trial means a Clinical Trial of a Product on sufficient numbers of normal volunteers and/or patients that is designed to establish that such Product is safe for its intended use and to support its continued testing in Phase 2 Clinical Trials. For purposes of this Agreement, ‘initiation’ of a Phase 1 Clinical Trial for a Product means the first dosing of such Product in a human subject in a Phase 1 Clinical Trial.

  • Phase 4 Clinical Trial means a Clinical Trial of a Product conducted after Regulatory Approval of such Product has been obtained from an appropriate Regulatory Authority, which trial is (a) conducted voluntarily by a Party to enhance marketing or scientific knowledge of the Product, or (b) conducted due to a request or requirement of a Regulatory Authority.

  • Phase IV Clinical Trial means a post-registrational Clinical Trial conducted in any country or countries and required as a condition to, or for the maintenance of, any Regulatory Approval for a Product in the Territory.

  • Phase II Clinical Trial means a study in humans of the safety, dose ranging and efficacy of a product, which is prospectively designed to generate sufficient data (if successful) to commence a Phase III Clinical Trial or to file for accelerated approval, or otherwise consistent with the requirements of U.S. 21 C.F.R. §312.21(b) or its foreign equivalents.

  • Clinical Trial means a Phase I Clinical Trial, Phase II Clinical Trial or Phase III Clinical Trial, or any post-approval human clinical trial, as applicable.

  • 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.

  • Pivotal Clinical Trial means, with respect to a Licensed Product, (a) a phase 3 Clinical Trial or (b) any other clinical trial that is intended (as of the time the study is initiated) to obtain the results and data to support (without the need to conduct any additional clinical trial) the filing of an application for Regulatory Approval for such product.

  • 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 IIb Clinical Trial means a clinical trial of a Product on sufficient numbers of patients that is designed to provide a preliminary determination of safety and efficacy of such Product in the target patient population over a range of doses and dose regimens.

  • Approved clinical trial means a phase I, phase II, phase III, or phase IV clinical trial that is conducted in relation to the prevention, detection, or treatment of cancer or other life-threatening disease or Condition and is described in any of the following:

  • Phase I Clinical Study means, as to a particular Licensed Product, an initial clinical study in humans with the purpose of assessing the Licensed Product’s safety, tolerability, toxicity, pharmacokinetics or other pharmacological properties.

  • Clinical Trials means a controlled study in humans of the safety or efficacy of a Product, and includes, without limitation, such clinical trials as are designed to support expanded labeling or to satisfy the requirements of an Agency in connection with any Product Approval and any other human study used in research and Development of a Product.

  • Phase II Clinical Study means a human clinical study of a product initiated to determine the safety and efficacy in the target patient population, as described 21 C.F.R. 312.21(b).

  • Phase III Clinical Study means a pivotal Clinical Study, the results of which could be used to establish safety and efficacy of a Licensed Product in the Field as a basis for Regulatory Approval or that would otherwise satisfy requirements of 21 CFR 312.21(c), or its foreign equivalent.

  • Clinical Study or “Clinical Studies” means a Phase 0 Xxxxx, Xxxxx 0 Xxxxx, Xxxxx 0 Trial or Phase 4 Trial, or such other study in humans that is conducted in accordance with good clinical practices and is designed to generate data in support or maintenance of an NDA, MAA or other similar marketing application.

  • Clinical means having a significant relationship, whether real or potential, direct or indirect, to the actual rendering or outcome of dental care, the practice of dentistry, or the quality of dental care being rendered to a patient;

  • Clinical laboratory means a facility for the microbiological, serological, chemical, hematological, radiobioassay, cytological, immunohematological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of a disease or assessment of a medical condition.

  • Clinical Studies means any clinical studies of a Licensed Product conducted on humans.

  • Study means the investigation to be conducted in accordance with the Protocol.

  • FDA means the United States Food and Drug Administration and any successor agency thereto.

  • Licensed clinical social worker means an individual who meets the licensed clinical social worker requirements established in KRS 335.100.