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.
Sample 1Sample 2Sample 3
Preclinical Research means, with respect to a particular Collaboration Program, any discovery, preclinical CMC and other research and development activities as set forth in a Work 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 the relevant Collaboration Product and preparing regulatory documents therefor, and up to and including the filing of an IND for the relevant Collaboration Product.
Sample 1
Preclinical Research means preclinical and nonclinical research activities.
Sample 1

Examples of Preclinical Research in a sentence

  • The CFDA published standards and technical procedures for the collection, manufacture, and storage of stem cells for clinical use in the ‘Stem Cell Preparations Quality Control and Pre-clinical Research Guidelines’ (CFDA 2015); it also specified the required criteria for safety and efficacy assessment in preclinical studies.

  • 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.

  • Freedman et al., The Economics of Reproducibility in Preclinical Research, 16(4) PLOS BIOLOGY1, at 2 (2015); Victoria Stodden, Enhancing reproducibility for computational methods, 354(6317) SCIENCE 1240 (2016).

  • Baseline CMR images of case 2Case 2: A 32-year-old Caucasian male was referred to the cardiology clinic with palpitations and a family history of LVNC.

  • The number of Professional Nurses in the public system also increased significantly by 35% or 3.9% each year.22 While much of the increase in the number of Medical Practitioners could be attributed to the introduction of mandatory community service of two years for all graduates it is an important achievement nonetheless.

  • Ioannidis JPA (2017): Acknowledging and Overcoming Nonreproducibility in Basic and Preclinical Research.

  • I observe in conclusion that if the Claimant believes strongly in the substantive merits of her case by far her best strategy would be to ensure that a final hearing is effective at the earliest possible date.

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

  • However, authorities do have a responsibility to prevent stopping up.

  • Notices to VDx shall be addressed to: VDx – Preclinical, 215 C Street, Suite 301, Davis, CA 95616, attention: Preclinical Research Manager, Facsimile (530) 753-4055, email: RST@vdxpathology.com.


More Definitions of Preclinical Research

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.
Sample 1

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 methodical investigation into a subject.

  • 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 Study in any country which is conducted after Regulatory Approval of a product has been obtained from an appropriate Regulatory Authority, consisting of trials conducted voluntarily for enhancing marketing or scientific knowledge of an approved indication and trials conducted due to 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, as to a particular Licensed Product, an initial clinical study in humans with the purpose of assessing the Licensed Product’s safety, tolerability, toxicity, pharmacokinetics or other pharmacological properties.

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

  • Clinical Studies means Xxxxx 0, Xxxxx 0, Xxxxx 0, Xxxxx 3, and such other tests and studies in human subjects that are required by Applicable Law, or otherwise recommended by the Regulatory Authorities, to obtain or maintain Regulatory Approvals for a Licensed Product for one (1) or more indications, including tests or studies that are intended to expand the Product Labeling for such Licensed Product with respect to such indication.

  • 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.

  • 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 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.

  • 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 pivotal human clinical trial of a Licensed Product with a defined dose or a set of defined doses of such Licensed Product designed to ascertain efficacy and safety of such Licensed Product for the purpose of enabling the preparation and submission of an MAA to the competent Regulatory Authorities in a country of the Territory, as further defined in 21 C.F.R. § 312.21(c) for the U.S., as amended from time to time, or the corresponding foreign regulations.

  • 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.