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.
Sample 1Sample 2Sample 3
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
Sample 1Sample 2
Phase I Clinical. Trial” 10 1.48 “Phase II Clinical Trial” 10
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Examples of Phase I Clinical in a sentence

  • 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.

  • 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.

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

  • 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.

  • 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 role of the Project Liaison shall terminate upon the Initiation of the first Phase I Clinical Trial with respect to a Product.

  • The Project Liaisons shall be the primary contact between the Parties with respect to the Research Programs as well as with respect to subsequent Development activities hereunder until the Initiation of the first Phase I Clinical Trial with respect to a Product.

  • Initiation of the respective phase of the clinical study shall be deemed to be achieved after the dosing of the first patient (or, in the event of a Phase I Clinical Study, of the first healthy person) in such clinical study.

  • Notwithstanding Licensor’s responsibilities and decision-making rights set forth with regard to the PRC Phase I Dose Escalation Clinical Trial, the PRC Phase I Expansion Cohort Clinical Trial, and the Ex-PRC Phase I Dose Escalation Clinical Trial, Licensor agrees to consult and review with Company, through the JAC, the design of such planned Phase I Clinical Trials, and allow Company to review and comment on the respective draft protocols.


More Definitions of Phase I Clinical

Phase I Clinical. Trial shall mean studies in humans to obtain initial data regarding solely the safety of an R&D Candidate.
Sample 1Sample 2
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 1.64 “Regulatory Approval” 11
Sample 1
Phase I Clinical. Trials” 5
Sample 1
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.
Sample 1

Related to Phase I Clinical

  • 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 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 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.

  • 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.

  • 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 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 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 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, the principal purpose of which is preliminary determination of safety of an investigational product in healthy individuals or patients or that otherwise meets the requirements described in 21 C.F.R. §312.21(a), or similar Clinical Trial in a country other than the United States.

  • 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 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.

  • 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 human clinical trial, for which the primary endpoints include a determination of dose ranges and/or a preliminary determination of efficacy in patients being studied as described in 21 C.F.R. § 312.21(b) (FDCA), as amended from time to time, and the foreign equivalent thereof.

  • 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 any human clinical trial of a Product.

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

  • 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.