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

  • A First-In- Human Clinical Trial of Adoptive Therapy Using CD19-Specific Chimeric Antigen Receptor Re-Directed T-Cells for Recurrent/Refractory Follicular Lymphoma.

  • Prior to the commencement of any Human Clinical Trial, the Insured shall ensure that all applicable statutory and regulatory requirements and professional guidelines and standards have been complied with in respect of that Human Clinical Trial.

  • By: /s/ Xxxxxxx Xxxxxx Xxxxxxx Xxxxxx, President Date: June 2, 2006 Date: 6-02-06 Phase V - Human Clinical Trial / Phase VI - Marketing Approval Assumptions Investigational Plan CL-7000, Rev.

  • 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.

  • That same day, Goodyear conducted a conference call with Wall Street analysts to discuss its fourth quarter and year end results.Gibara, Keegan and Tieken participated in the call and reiterated Goodyear’s reported net loss for the period of $174 million.

  • In order to maintain the Exclusive NCE status of a particular Chemical Entity, the applicable Party must initiate (i.e., administration of the first dose to the first patient) a First in Human Clinical Trial with respect to such Chemical Entity within [***] of the date of the IND filing that caused such Chemical Entity to become an Exclusive NCE.

  • First in Human Clinical Trial of Ultrasonic Propulsion of Kidney Stones.

  • Such supplementary funding must be disclosed, fully, to MDA as part of the Human Clinical Trial grant application or at the time such funding is received.

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

  • Planned Phase 2 Human Clinical Trial for Prevention of AIDS The Company’s Phase 2 trial, conducted by the U.S. National Institutes of Health (NIH) supported HIV Vaccine Trials Network (HVTN), will involve 225 healthy volunteers from the United States and South America, and will further evaluate the safety and immunogenicity of the GeoVax preventative vaccine (vaccine administered prior to infection with the HIV virus).


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, for which the primary endpoints include a determination of dose ranges or an indication of efficacy in patients being studied as described in 21 C.F.R. §312.21(b), or an equivalent clinical trial in a country in the Territory 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 product support clinical trial of a Product commenced after receipt of Regulatory Approval in the country where such trial is conducted. A Phase IV Clinical Trial may include epidemiological studies, modeling and pharmacoeconomic studies, and investigator-sponsored clinical trials studying Product that are approved by the JDC and that otherwise fit the foregoing definition.

  • Phase II Clinical Trial means a controlled human clinical study that would satisfy the requirements of 21 CFR 312.21(b), conducted to study the effectiveness and establish the dose range of a Product for a particular Indication in patients with the disease or condition under study, including a Phase IIA Clinical Study or Phase IIB Clinical Study.

  • Clinical Trial means any human clinical trial of a Product.

  • 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 a human clinical trial in any country that is prospectively designed to generate data intended to satisfy the requirements of 21 C.F.R. § 312.21(c) (as amended) in the U.S. or a similar clinical study prescribed by a Regulatory Authority from another country, from time to time, pursuant to Applicable Law.

  • Phase III Clinical Trial means a human clinical trial of a product, the design of which is acknowledged by the FDA to be sufficient for such clinical trial to satisfy the requirements of 21 C.F.R. 312.21(c) (as amended or any replacement thereof), or a similar human clinical trial prescribed by the Regulatory Authority in a country other than the United States, the design of which is acknowledged by such Regulatory Authority to be sufficient for such clinical trial to satisfy the requirements of a pivotal efficacy and safety clinical trial.

  • 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 a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • 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 trial involving administration of a Compound to sufficient numbers of human patients with the goal of establishing that the Compound is safe and efficacious for its intended use, to define warnings, precautions and adverse reactions that are associated with the drug or label expansion of such Compound, and to be considered as a pivotal study for submission of an NDA.

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, as applicable.

  • 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.

  • Participating Clinical Laboratory means a Clinical Laboratory which has a written agreement with the Claim Administrator or another Blue Cross and/or Blue Shield Plan to provide services to you at the time services are rendered.

  • Clinical Studies means human clinical trials for a Licensed Product and any other tests and studies for a Licensed Product in human subjects.

  • Subject of a Clinical Trial means the health care service, item, or drug that is being evaluated in the Approved Clinical Trial and that is not a Routine Patient Cost.

  • 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.