SMALL MOLECULE DRUG definition

SMALL MOLECULE DRUG means any pharmaceutical compound for the treatment of any human or animal disease or condition, the active ingredient of which is a synthetically prepared, or a naturally derived chemical compound [**]; provided, however, that "Small Molecule Drug" specifically excludes any compound which consists of or incorporates as an active ingredient a Protein, a Derivative Protein, a nucleic acid oligomer, or an antibody or any fragment thereof.
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SMALL MOLECULE DRUG means a small molecule therapeutic product within the Field originating from a screen using a Validated Target, other than a Candidate Protein Drug, an Analog Protein Drug, a Peptido Mimetic Drug, a Modified Drug, a Gene Therapy Drug or an Antisense Drug.
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SMALL MOLECULE DRUG shall not include any pharmaceutical product in which the active ingredient is (i) a Protein, (ii) any vaccine, (iii) an antibody (whether polyclonal or monoclonal, multiple or single chain, whole or fragment), (iv) a nucleic acid
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Examples of SMALL MOLECULE DRUG in a sentence

  • Ex-vivo study on therapeutic efficacy of three YKL40 inhibitors and reference compound on cell and tissue IPF models.The order is carried out as a part of the project titled: - YKL-40: “DEVELOPMENT OF A FIRST-IN-CLASS SMALL MOLECULE DRUG CANDIDATE FOR CANCERTREATMENT THROUGH YKL 40 INHIBITION” (POIR.01.01.01-00-0552/16) co-financed by the European Union Funds and because of the competitiveness principle.

  • The order is carried out as a part of the projects titled: ⎯ IPF: “DEVELOPMENT OF A FIRST-IN-CLASS SMALL MOLECULE DRUG CANDIDATE FOR TREATMENT OF IDIOPATHIC PULMONARY FIBROSIS THROUGH CHITOTRIOSIDASE INHIBITION” (POIR.01.01.01-00- 0551/15)⎯ YKL-40: “DEVELOPMENT OF A FIRST-IN-CLASS SMALL MOLECULE DRUG CANDIDATE FOR CANCER TREATMENT THROUGH YKL 40 INHIBITION” (POIR.01.01.01-00-0552/16)co-financed by the European Union Funds and because of the competitiveness principle.

  • SO IT'S 18 A SMALL MOLECULE DRUG THAT ACTS ON ENDOGENOUS 19 CARTILAGE PROGENITOR CELLS TO STIMULATE CARTILAGE 20 GROWTH.

  • The order carried out as a part of the project titled: - YKL-40: “DEVELOPMENT OF A FIRST-IN-CLASS SMALL MOLECULE DRUG CANDIDATE FOR CANCER TREATMENT THROUGH YKL40 INHIBITION” (POIR.01.01.01-00-0552/16) co-financed by European Union Funds and because of the competitiveness principle.

  • INTEGRATED SMALL MOLECULE DRUG SUBSTANCE/DRUG PRODUCT PROCESSES 312.1. Characteristics of Drug Substance and Drug Product Process Steps 312.2. Example of an Integrated Process 312.3. Process Design, Monitoring and Control 332.4. Start-up and Shutdown 332.5. RTD Characterisation for System Dynamics and Material Traceability 333.

  • The performance of the inner container adds to the overall performance and level of safety of the package design (see Section 2.1.2).

  • SMALL MOLECULE DRUG DISCOVERY Small molecule drugs are therapeutic compounds designed to be administered orally.

  • Closing date: 08 Feb 17 Website:http://grants.nih.gov/grants/guide/pa- files/PAR-14-288.html BLUEPRINT NEUROTHERAPEUTICS NETWORK: SMALL MOLECULE DRUG DISCOVERY AND DEVELOPMENT FOR DISORDERS OF THE NERVOUS SYSTEM (UH2/UH3)NIH: National Institute of Neurological Disorders and Stroke The purpose of this UH2/UH3 funding opportunity announcement is to help neuroscience investigators seeking support to advance their small molecule drug discovery and development projects into the clinic.

  • Johan van Benthem and Eric Pacuit ([21]) propose to represent such a piece of evidence an agent receives as the set of all the worlds where the piece of evidence provides evidence for.Example 1.

  • INTEGRATED SMALL MOLECULE DRUG SUBSTANCE/DRUG PRODUCT PROCESSES 292.1. Characteristics of Drug Substance and Drug Product Process Steps 292.2. Example of an Integrated Process 292.3. Process Design, Monitoring and Control 302.4. Start-up and Shutdown 312.5. RTD Characterisation for System Dynamics and Material Traceability 313.


More Definitions of SMALL MOLECULE DRUG

SMALL MOLECULE DRUG means any therapeutic agent, the active ingredient in which is a Small Molecule, that (a) is identified on the basis of its interaction with a Qualified Target in a Small Molecule screening assay, or (b) is designed or developed using medicinal chemistry, combinatorial chemistry, rational design techniques or other techniques to interact with a Qualified Target. The term "Small Molecule Drug" shall not include any pharmaceutical product in which the active ingredient is (i) a Protein, (ii) any vaccine, (iii) an antibody (whether polyclonal or monoclonal, multiple or single chain, whole or fragment), (iv) a nucleic acid
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SMALL MOLECULE DRUG means a small-molecule therapeutic product, identified in an assay using a Validated Target, other than a Peptidomimetic Drug, Antisense Drug, Protein Drug, Derivative Protein Drug, Analog Protein Drug, Protein Mimetic Drug, Gene Therapy Drug, Vaccine or Antibody Drug. "Stock Purchase, Standstill and Registration Rights Agreement" shall mean the Stock Purchase, Standstill and Registration Rights Agreement by and between ARIAD and HMRI dated as of March 4, 1997.
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SMALL MOLECULE DRUG means a therapeutic or prophylactic product, the active ingredient of which is a synthetic small molecule (including but not limited to a Peptido Mimetic), a natural product or a macromolecule that (a) is identified in a screening assay on the basis of its interaction with a biological target that has been identified through use of a Program Clone, or (b) is designed or developed using medicinal chemistry, SAR or combinatorial chemistry techniques to interact with a biological target that has been identified through use of a Program Clone, provided, however, that a Small Molecule Drug does not include any Therapeutic Product or any therapeutic and/or prophylactic product in which the active ingredient is a Protein, an Antibody, an Antisense Drug or a Gene Therapy Drug.
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SMALL MOLECULE DRUG shall not include any pharmaceutical product in which the active ingredient is [**].
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SMALL MOLECULE DRUG has the meaning set forth for such term in the Collaboration Agreement between MBI and Eli Xxxlx xxx Company to be executed on or about the Effective Date.
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Related to SMALL MOLECULE DRUG

  • Generic Drug means a prescription drug approved under 21 U.S.C. § 355(j) or 42 U.S.C. 262(k).

  • Licensed Compound means a TAK-385 Licensed Compound or a TAK-448 Licensed Compound.

  • Cancer drug means a prescription drug used to treat:

  • 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”).

  • 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)).

  • Diagnostic Product means an assemblage of reagents, including but not limited to reagents packaged in the form of a kit, useful in performing a Licensed Service.

  • Antibody means a molecule or a gene encoding such a molecule comprising or containing one or more immunoglobulin variable domains or parts of such domains or any existing or future fragments, variants, modifications, or derivatives thereof, but excluding single variable domains (heavy or light) of such antibodies.

  • Phase IV Clinical Trial means a post-registrational Clinical Trial conducted in any country or countries and required as a condition to, or for the maintenance of, any Regulatory Approval for a Product in the Territory.

  • Biomarker means a characteristic that is objectively measured and evaluated as an indicator of normal biological processes, pathogenic processes, or pharmacologic responses to a specific therapeutic intervention. Biomarkers include, but are not limited to, gene mutations or protein expression.

  • Exempt compound means the same as defined in Rule 2.

  • 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.

  • Biological Samples means any physical samples obtained from Study Participants in accordance with the Protocol for the purposes of the Study.

  • New drug means: (i) any drug, except a new animal drug or an animal feed bearing or containing

  • 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.

  • Product Candidate means each biological and drug candidate, compound or other device or product being developed, labeled, manufactured, marketed, sold and/or distributed by the Company or a Company Subsidiary, or regarding which the Company or a Company has rights, and including any such biological and drug candidate, compound or product that has received Marketing Approval.

  • 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.

  • Compound means the taking of two or more ingredients and fabricating them into a single

  • 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 II Clinical Trial means a study in humans of the safety, dose ranging and efficacy of a product, which is prospectively designed to generate sufficient data (if successful) to commence a Phase III Clinical Trial or to file for accelerated approval, or otherwise consistent with the requirements of U.S. 21 C.F.R. §312.21(b) or its foreign equivalents.

  • Active Pharmaceutical Ingredient or “API” shall mean one or more of the following active pharmaceutical ingredients: tenofovir alafenamide (“TAF”), tenofovir disoproxil fumarate (“TDF”), elvitegravir (“EVG”), and cobicistat (“COBI”).

  • 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.

  • Biosimilar Product means, with respect to a Licensed Product and on a country-by-country basis, a product that [***].

  • Manufacturing Know-How means all information, techniques, inventions, discoveries, improvements, practices, methods, knowledge, skill, experience and other technology, whether or not patentable or copyrightable, and any copyrights based thereon, relating to or necessary or useful for the production, purification, packaging, storage and transportation of Collaboration Products, including without limitation specifications, acceptance criteria, manufacturing batch records, standard operating procedures, engineering plans, installation, operation and process qualification protocols for equipment, validation records, master files submitted to the FDA, process validation reports, environmental monitoring processes, test data including pharmacological, toxicological and clinical test data, cost data and employee training materials.

  • 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.

  • 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.

  • Covered drug means any prescription drug that: