Preclinical Research definition

Preclinical Research means the conduct of laboratory research and/or the conduct of preclinical safety and/or efficacy and/or toxicology studies in vitro and/or in vivo in any non-human species including, without limitation, IND enabling studies.
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Preclinical Research means, with respect to a particular Collaboration Target, any discovery, preclinical CMC and other research and development activities relating to any Product Directed Against such Collaboration Target as set forth in a Preclinical Research Plan (including post-clinical candidate selection activities), and any advisory or consulting services provided in connection therewith, including with respect to filing of an IND for such Product and preparing regulatory documents therefor, and up to and including the filing of an IND for such Product.
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Preclinical Research means any and all activities related to the design, discovery, identification, research, preclinical development, preclinical toxicology studies, profiling, characterization, improvement, or optimization of a product prior to the filing of an IND for such product.
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Examples of Preclinical Research in a sentence

  • Module 1A: Pre-clinical Research Scope• Development and implementation of high-throughput pre-clinical predictive models for (A) validation of data and hypotheses from human population, clinical, molecular and genomics studies and/or (B) prediction of clinical outcome.

  • Module 1A: Pre-clinical Research Scope Development and implementation of high-throughput pre-clinical models for (A) validation of data and hypotheses from human population, clinical and molecular studies and/or (B) prediction of clinical outcome.

  • The Parties agree that, unless otherwise agreed in writing, the Amgen payments to EnteraBio contemplated in Section 7.1.1 (Technology Access Payment; Upfront Payment) and 7.1.2 (R&D Costs) shall cover EnteraBio’s internal Preclinical Research and Development Costs for the first two years of each Collaboration Program.

  • For clarity, after completion of the applicable Work Plan, Amgen shall continue to have the right to conduct Preclinical Research & Development with respect to the applicable Products.

  • During the Preclinical R&D Term for each Collaboration Program, Amgen hereby grants to EnteraBio a non-exclusive, worldwide, royalty-free right under Amgen IP solely to conduct Preclinical Research & Development as contemplated to be performed by EnteraBio under each Work Plan.

  • On an annual basis, the JSC shall discuss in good faith and approve an annual budget for EnteraBio out-of-pocket Preclinical Research and Development Costs for each Collaboration Program (each, an “Annual Out-of-Pocket Budget”), which shall include an agreed-upon timeline for any Amgen prepayment of anticipated out-of-pocket Preclinical Research & Development Costs.

  • Antoni1,211121314 1 Division of Preclinical Research, Egis Pharmaceuticals PLC, Budapest, Hungary151716 2 Centre for Discovery Brain Sciences, Deanery of Biomedical Sciences University of1819 Edinburgh, Edinburgh, Scotland, U.K.,2021 3 Human Brain Tissue Bank and Laboratory, Semmelweis University, Budapest,2223 4 Semmelweis University Heart and Vascular Center, Budapest, Hungary,2425262728 Corresponding author: Ferenc A.

  • Notwithstanding anything in this Agreement to the contrary, EnteraBio shall have no obligation to conduct (or engage any Affiliate or Third Party subcontractor to conduct) any Preclinical Research & Development activity if the Parties have not agreed on Amgen’s reimbursement of the EnteraBio internal and out-of-pocket Preclinical Research & Development Costs incurred in connection with such activity pursuant to Section 3.1.2(a) and/or (b).

  • Business hours 9: 30 - 14: 00, tel./fax 22 621 75 43 Department of Methodology Preclinical Research Center Bldg.

  • Each subcontracting Party will, and will contractually require that its Affiliates and subcontractors, if any, conduct the relevant Preclinical Research & Development activities in accordance with such subcontracting Party’s commitments with respect to the applicable Work Plan.


More Definitions of Preclinical Research

Preclinical Research means preclinical and nonclinical research activities.
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Related to Preclinical Research

  • Clinical evaluation means a systematic and planned process to continuously generate, collect, analyse and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer;

  • Clinical review criteria means the written screening procedures, decision abstracts, clinical protocols, and practice guidelines used by a health carrier to determine the necessity and appropriateness of health care services.

  • Research Analyst means any individual employed by Loomis Sayles who has been designated as a Research Analyst or Research Associate by Loomis Sayles. A person is considered a Research Analyst only as to those Covered Securities which he or she is assigned to cover and about which he or she issues research reports to other Investment Persons or otherwise makes recommendations to Investment Persons beyond publishing their research. As to other securities, he or she is simply an Access Person.

  • Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.

  • scientific research means any activity in the field of natural or applied science for the extension of knowledge;

  • 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 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 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.

  • 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.

  • Public research university means Rutgers, The State University

  • Collaborative drug therapy management means participation by an authorized pharmacist and a physician in the management of drug therapy pursuant to a written community practice protocol or a written hospital practice protocol.

  • 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).

  • Research Use shall have the meaning given in Section 2.2.2 of this Agreement.

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

  • Clinical Development means the conduct of clinical trials in humans to assess the dosing, safety and/or efficacy of the Product, including but not limited to Phase I Clinical Trials, Phase II Clinical Trials, Phase Ill Clinical Trials and Phase IV Clinical Trials.

  • 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.

  • Radiopharmaceutical quality assurance means, but is not limited to, the performance of appropriate chemical, biological, and physical tests on potential radiopharmaceuticals and the interpretation of the resulting data to determine their suitability for use in humans and animals, including internal test assessment, authentication of product history, and the keeping of proper records.

  • 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.

  • Clinical record means a legible electronic or hard-copy history that documents the criteria established for medical records as set forth in rule 441—79.3(249A). A claim form or billing statement does not constitute a clinical record.

  • 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.

  • 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 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).

  • 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.