Phase I Clinical definition

Phase I Clinical. Trial shall mean a human clinical trial normally conducted in healthy volunteers with the aim of establishing the pharmacokinetic, pharmacodynamic and early safety profile.
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Phase I Clinical. Trial” 10 1.48 “Phase II Clinical Trial” 10
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Phase I Clinical. Trial shall mean studies in humans to obtain initial data regarding solely the safety of an R&D Candidate.
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Examples of Phase I Clinical in a sentence

  • Percutaneous mitral valve repair using the edge-to-edge technique: six-month results of the EVEREST Phase I Clinical Trial.

  • The new guidelines Previous guidelines in this area have been replaced in order to reflect the agreed ABPI position: the 1988 Non-Patient Guidelines are now replaced by the compensation provisions set out in the Phase I Clinical Trials Compensation Guidelines; and the 1991 Clinical Trial Guidelines are now replaced by the compensation provisions set out in the Phases II, III and IV Clinical Trials Compensation Guidelines.

  • Consequential changes to the relevant section on compensation in the ABPI’s Guidelines For Phase I Clinical Trials (2012 Edition) have also been made.

  • Legedza, ATR, Ibrahim, JG, “Heterogeneity in Phase I Clinical Trials: Prior Elicitation and Computation Using the Continual Reassessment Method,” Statistics in Medicine, 2001; 20:867–882.

  • Legedza, ATR, and Ibrahim, JG “Longitudinal Design for Phase I Clinical Trials Using the Continual Reassessment Method,” Controlled Clinical Trials, 2000; 21:574–588.

  • Notwithstanding the foregoing, if Merck shall at any time commence a Phase I Clinical Trial on a Compound without having formally exercised its Development Election, Merck shall be deemed to have exercised its Development Election with respect to such Compound.

  • The Sponsor must provide any ongoing safety and toxicology data updates to the Principal Investigator immediately, to ensure the safety of the Clinical Trial Subjects in this Phase I Clinical Trial.

  • The [Sponsor][CRO] (delete as appropriate) must provide any ongoing safety and toxicology data updates to the Principal Investigator immediately, to ensure the safety of the Clinical Trial Subjects in this Phase I Clinical Trial.

  • June 30, 2017 · Initiate Neon-sponsored Phase I Clinical Study for the Licensed NeoVax Product.

  • Details of such procedures shall be agreed upon by the Parties prior to the initiation of Phase I Clinical Trials by or on behalf of MITSUBISHI.


More Definitions of Phase I Clinical

Phase I Clinical. Study” 11 Section 1.66 “Phase II Clinical Study” 11 Section 1.67 “Phase III Clinical Study” 11 Section 1.68 “Phase IV Clinical Study” 12 Section 1.69 “Prosecution and Maintenance” or “Prosecute and Maintain” 12 Section 1.70 “Regulatory Approval” 12 Section 1.71 “Regulatory Authority” 12 Section 1.72 “Regulatory Documentation” 12 Section 1.73 “Regulatory Expenses” 12 Section 1.74 “Right of Reference or Use” 13 Section 1.75 “Royalty Term” 13 Section 1.76 “SEC” 13 Section 1.77 “Solid Tumor Indication” 13 Section 1.78 “Specifications” 13 Section 1.79 “Sublicense Revenue” 13 Section 1.80 “Taiwan” 15 Section 1.81 “Terminated Territory” 15 Section 1.82 “Terminated Territory Royalty Term” 15 Section 1.83 “Third Party” 15 Section 1.84 “US” or “USA” 15 Section 1.85 “Valid Claim” 15 Section 1.86 Additional Definitions 15
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Phase I Clinical. Trial” 10 1.60 “Phase II Clinical Trial” 10 1.61 “Phase III Clinical Trial” 10 1.62 “Program Molecule” 10 1.63 “Program Patent Rights” 10 Page
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Phase I Clinical. Study shall mean a clinical study of the Product in human volunteers or patients with the endpoint of determining initial tolerance, toxicity, safety and/or pharmacokinetic information, which shall be deemed commenced when the third volunteer or patient in such study has received his or her initial dose of the Product.
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Phase I Clinical. Trials” 5
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Related to Phase I Clinical

  • Phase I Clinical Trial means a clinical trial conducted in healthy humans or patients, which clinical trial is designed to establish the safety, drug-drug interactions and/or pharmacokinetics of an investigational drug given its intended use, and to support continued testing of such drug in Phase II Clinical Trials.

  • 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).

  • 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.

  • 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 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 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 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 III Clinical Study means a human clinical study of a product on a sufficient number of subjects that is designed to establish that such product is safe and efficacious for its intended use, and to determine warnings, precautions, and adverse reactions that are associated with such product in the dosage range to be prescribed, which trial is intended to support Regulatory Approval of such product, as described in 21 C.F.R. 312.21(c). 1.185. [***] 1.186. [***]

  • Phase III Clinical Trial means a human clinical trial, the principal purpose of which is to demonstrate clinically and statistically the efficacy and safety of a Licensed Product for one or more indications in order to obtain Marketing Approval of such Licensed Product for such indication(s), as further defined in 21 C.F.R. §312.21 or a similar clinical study in a country other than the United States.

  • Phase IV Clinical Trial means a Clinical Trial conducted after a Product achieves Regulatory Approval, carried out for purposes of conducting safety surveillance and ongoing technical support of the Product.

  • 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 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 I Study means a study in humans which provides for the first introduction into humans of a product, conducted in healthy volunteers or patients to obtain information on product safety, tolerability, pharmacological activity or pharmacokinetics, as more fully defined in 21 C.F.R. § 312.21(a) (or the non-United States equivalent thereof).

  • 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:

  • 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;

  • Phase I Trial means a clinical trial of a Licensed Product in human patients conducted primarily for the purpose of determining the safety, tolerability and preliminary activity of the Licensed Product, including, without limitation, for determining the maximum tolerated dose, or optimal dose. For purposes of this Agreement, a Phase I trial shall specifically exclude a study in healthy volunteers.

  • 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.

  • 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.

  • 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.

  • Phase II Study means a study in humans of the safety, dose ranging or efficacy of a product, as further defined in 21 C.F.R. § 312.21(b) (or the equivalent thereof outside the United States).

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

  • Phase III Study means a human clinical trial that is prospectively designed to demonstrate statistically whether a product is safe and effective for use in humans in a manner sufficient to obtain regulatory approval to market such product in patients having the disease or condition being studied as described in 21 C.F.R. § 312.21(c) (FDCA), as amended from time to time, and the foreign equivalent thereof.

  • 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.

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, or Pivotal Study, as applicable; but excluding any Post-Approval Studies.

  • Non-Participating Clinical Laboratory means a Clinical Laboratory which does not have a written agreement with the Claim Administrator or another Blue Cross and/or Blue Shield Plan provide services to you at the time services are rendered.

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