Preclinical Candidate definition

Preclinical Candidate means a compound which is or is derived from a Lead Compound which is determined by the Research Committee to be appropriate for pharmacology, toxicology, ADME, formulation and process development studies for IND filing in the Sumitomo Territory.
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Preclinical Candidate shall have the meaning given it in the Collaboration Agreement.
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Preclinical Candidate means a Collaboration Compound for which a [**] has been made.
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Examples of Preclinical Candidate in a sentence

  • About Prestwick Chemical SASPrestwick Chemical is a French contract research organization, offering medicinal chemistry services (from Hit Discovery to Pre-clinical Candidate) as well as innovative smart compound collections dedicated to screening.

  • These Decision trees offer a guide on which of the test systems and sequence of Test Systems can be practically employed from Hit-2-Lead, Lead Optimization and Pre-clinical Candidate selection.

  • For clarity, the Parties may agree in writing to conduct additional activities as part of the Research Program beyond those specified in the initial Research Plans (e.g., development of Collaboration Compounds meeting Preclinical Candidate criteria), but any such activities shall require additional funding and mutual written agreement on modifications to the relevant Research Plan and Budget.

  • Promptly (but no later than thirty (30) days) following approval of the first Preclinical Candidate, Merck and Metabasis shall establish a Joint Development Committee (the “Joint Development Committee” or “JDC”) with an equal number of (not to exceed four (4)) representatives of each party.

  • This drug “hit” is then optimised to provide a compound(often termed a Preclinical Candidate) which has the potency, specificity and pharmaceutical properties to interact with the target in humans at a therapeuticconcentration which does not cause unacceptable side effects.

  • Indolcarboxamide Is a Preclinical Candidate for Treating Multidrug-Resistant Tuberculosis.

  • Signature of individual completing the assessment is required: Evaluator’s Signature: Title: Date: Candidate’s Signature: Date: Faculty Advisor: Date: Preclinical Candidate Dress Code‌The professional status of a candidate as a teacher is, in part, determined and reinforced by appropriate dress and appearance.

  • After approval of an IND for a Preclinical Candidate, the Research Committee may designate that Preclinical Candidate as a Clinical Candidate for the purposes of this Section 3.5. Neither party will commence Clinical Development of any Collaboration Compound or Derivative before such compound has been designated as a Clinical Candidate in accordance with this Section.

  • Best Practices of Computer-Aided Drug Discovery: Lessons Learned from the Development of a Preclinical Candidate for Prostate Cancer with a New Mechanism of Action.

  • The parties shall designate a Preclinical Candidate before commencing Preclinical.


More Definitions of Preclinical Candidate

Preclinical Candidate means a Collaboration Compound that the Research Committee has selected for Preclinical Development.
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Preclinical Candidate means a Collaboration Compound that Merck’s Preclinical Development Review Committee (or its successor committee) approves for entry into IND-Enabling GLP Toxicology Studies or that is actually entered into IND-Enabling GLP Toxicology Studies by Merck or a Related Party.
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Related to Preclinical Candidate

  • Development Candidate means a Compound that meets the Development Candidate Criteria for the initiation of a Development Program for the treatment of CF, and which is the subject of a notice from Vertex to CFFT that Vertex intends to commence formal pre-clinical development of the Compound in the Field pursuant to the provisions of Section 3.1 hereof.

  • Product Candidate means any pharmaceutical product developed, manufactured and/or tested by or on behalf of the Company that has not received a Regulatory Authorization for commercial distribution other than in connection with pre-clinical or clinical trials.

  • Collaboration Target means the Initial Collaboration Targets set forth on Exhibit F and any Additional Target or Substitute Target that is selected in accordance with Section 3.3 of this Agreement.

  • Collaboration Compound means any of the following: (a) FG-4592, (b) any HIF Compound (other than FG-4592) that is added to this Agreement pursuant to Section 3.6, and (c) any salts, esters, complexes, chelates, crystalline and amorphous morphic forms, pegylated forms, enantiomers (excluding regioisomers), prodrugs, solvates, metabolites and catabolites of any of the foregoing ((a) or (b)).

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

  • Lead Compound means any compound of lead other than galena which, when treated in the manner described below, yields to an aqueous solution of hydrochloric acid a quantity soluble lead compound exceeding, when calculated as lead monoxide, five percent of the dry weight of the portion taken analysis.

  • 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).

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

  • 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.

  • 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.

  • 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).

  • 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.

  • 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 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 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 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.

  • Licensed Compounds means: (a) Research Program Active Compounds; (b) Novartis Active Compounds; (c) salts, hydrates, solvates, esters, metabolites, intermediates, stereoisomers and polymorphs of Research Program Active Compounds or Novartis Active Compounds; and (d) prodrugs of Research Program Active Compounds or Novartis Active Compounds (any of the foregoing, a “Licensed Compound”).

  • 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.

  • POC means Point of Compliance. "POE" means Point of Exposure. "PSI" means pounds per square inch.

  • 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 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 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 Trial means any human clinical trial of a Product.

  • 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.

  • 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 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.