Nonclinical Studies definition

Nonclinical Studies means all in vivo and in vitro non-human studies of Collaboration Compounds and Products, including non-clinical pharmacology, toxicology, tumor and teratogenicity studies.
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Nonclinical Studies means all non-human studies, including preclinical studies and toxicology studies, of Collaboration Molecules and Products.
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Nonclinical Studies means all non-human animal studies, including preclinical studies and toxicology studies, of Licensed Products.
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Examples of Nonclinical Studies in a sentence

  • Within thirty (30) days after the end of each Calendar Quarter in which FibroGen conducts activities under the Development Plan for the RoW, FibroGen shall send to AstraZeneca an invoice for all costs incurred by FibroGen in such Calendar Quarter for such activities, including Personnel Costs, the Fully Burdened Cost of Collaboration Compound or Product or comparator drug, concomitant drug, placebo or other materials used in any Clinical Trial or Nonclinical Studies, and all other out-of-pocket costs.


More Definitions of Nonclinical Studies

Nonclinical Studies means all non-human animal studies, including preclinical studies and toxicology studies, of Galapagos Molecules and Optioned Molecules.
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Nonclinical Studies means all non-human animal studies for any Licensed Product, including preclinical studies, non-clinical and toxicology studies.
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Nonclinical Studies means all non-human studies, including preclinical studies and toxicology studies (including animal studies), of Licensed Products. 1.114 “[***]” or “[***]” means [***]
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Nonclinical Studies means all non-human studies, including preclinical studies and toxicology studies, of Eisai Collaboration Molecules and Eisai Collaboration Products.
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Nonclinical Studies means all preclinical and nonclinical in vivo and in vitro studies, including preclinical studies and toxicology studies, of Arcus Molecules and Optioned Molecules.
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Nonclinical Studies means, with respect to a Target, all preclinical and nonclinical studies in each case performed from such time when Assembly has initiated a Lead Selection Process for such Target, including in vivo and in vitro preclinical studies and toxicology studies, but excluding IND-enabling studies for such Target.
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Related to Nonclinical Studies

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

  • 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.

  • 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 I Clinical Trial means a study in humans which provides for the first introduction into humans of a product, conducted in normal volunteers or patients to generate information on product safety, tolerability, pharmacological activity or pharmacokinetics, or otherwise consistent with the requirements of U.S. 21 C.F.R. §312.21(a) or its foreign equivalents.

  • 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 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.

  • 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 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 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.

  • Studies means activities needed to prepare project implementation, such as preparatory, mapping, feasibility, evaluation, testing and validation studies, including in the form of software, and any other technical support measure, including prior action to define and develop a project and decide on its financing, such as reconnaissance of the sites concerned and preparation of the financial package;

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

  • Commercialization or “Commercialize” means activities directed to marketing, promoting, research and development as required, manufacturing for sale, offering for sale, distributing, importing or selling a product, including sub-licensing or sub-contracting of these activities.

  • Phase 3 Study means a clinical study of an investigational product in patients that incorporates accepted endpoints for confirmation of statistical significance of efficacy and safety with the aim to obtain Marketing Approval in any country as described in 21 C.F.R. 312.21(c), or a comparable Clinical Study prescribed by the relevant Regulatory Authority in a country other than the United States. The investigational product can be administered to patients as a single agent or in combination with other investigational or marketed agents and a Phase 3 Study shall be deemed commenced when Initiated.