Active Moiety definition

Active Moiety means the molecule or ion, excluding those appended por- tions of the molecule that cause the drug to be an ester, salt (including a salt with hydrogen or coordination bonds), or other noncovalent derivative (such as a complex chelate or clath- rate) of the molecule responsible for the physiological or pharmacological action of the drug substance.
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Active Moiety shall have the meaning assigned to that term under 21 CFR 314.108(a), as such regulation is in effect on the Effective Date, namely: “the molecule or ion, excluding those appended portions of the molecule that cause the drug to be an ester, salt (including a salt with hydrogen or coordination bonds), or other noncovalent derivative (such as a complex, a chelate or clathrate) of the molecule, responsible for the physiological or pharmacological action of the drug substance.”
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Active Moiety means the smallest chemical pharmacophoric element or three dimensional structure responsible for the physiological or pharmacological action of the drug substance.
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Examples of Active Moiety in a sentence

  • Effects of Temsavir, Active Moiety of Antiretroviral Agent Fostemsavir, on QT Interval: Results From a Phase I Study and an Exposure- Response Analysis.

  • Consider the following examples: Example 1FDA grants pediatric exclusivity on Active Moiety 1 (AM1).

  • This Contract may not be modified or amended except by a written document signed by the party against whom enforcement is sought.

  • Active Moiety Buproprion Glaxo Wellcome Buspirone Bristol-Myers Squibb Busulfan Orphan Medical Calcitriol Abbott Candesartan Astra Pharmaceuticals Carteolol CIBA Carvedilol SmithKline Beecham Celecoxib Searle Cerivastatin Bayer Cetirizine Pfizer Ciprofloxacin Bayer Ciprofloxacin Alcon Cisatracurium Glaxo Wellcome Citalopram Forest Laboratories Cromolyn Sodium Pharmacia & UpJohn Cromolyn Sodium Bausch & Lomb Cytarabine SkyePharma Inc.

  • If Amunix decides not to enforce an Amunix Patent to cease such infringement, Naia would like to enforce such Amunix Patent at its sole expense, and if such infringement is materially damaging to Naia’s interests in the Licensed Product or Active Moiety, the Parties shall negotiate in good faith in order to establish the framework for Naia to enforce such Amunix Patent.

  • Active Moiety t–he molecule or ion, excluding those appended portions of the molecule that cause the drug to be an ester, salt (including a salt with hydrogen or coordination bonds), or other noncovalent derivative (such as complex, chelate, or clathrate) of the molecule, responsible for the physiological or pharmacological action of the drug substance.

  • Just like every other taxicab or limousine company with Philadelphia rights, Germantown’s partial-rights taxicab authorization is now derived from the Authority.

  • Active Moiety Sponsor Abacavir Glaxo Wellcome Acetazolamide Wyeth-Ayerst Alosetron Glaxo Wellcome Amiodarone Wyeth Ayerst Amlexanox Block Drug Amlodipine Pfizer, Inc.

  • District Court Rejects FDA Interpretation of Active Ingredient as Active Moiety.

  • On Saturday, the site returned but the total num- bers of infections for states and the nation were no longer there.


More Definitions of Active Moiety

Active Moiety has the meaning set forth in Txxxx 00, Xxxxxx Xxxxxx Code of Federal Regulations, § 314.108(a).
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Active Moiety means the portion of a Research Construct and/or Licensed Product, in either case that is an engineered protein sequence, non-naturally occurring protein sequence, or a native protein sequence (including analog derivatives based on a native sequence) with binding affinity to a GLP-1 receptor Target Set that is responsible for biological activity. For avoidance of doubt, Active Moiety does not include an XTEN Sequence.
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Active Moiety means the molecule or ion, excluding those appended portions of the molecule that cause the drug to be an ester, salt (including a salt with hydrogen or coordination bonds) or other noncovalent derivative (such as a complex, chelate, or clathrate) of the molecule, responsible for the physiological or pharmacological action of the drug substance. CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
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Active Moiety means the portion of a Research Construct and/or Licensed Product, in either case, that is an engineered protein sequence, non-naturally occurring protein sequence, or a native protein sequence (including analog derivatives based on a native sequence) with binding affinity to a Target Set that is responsible for biological activity. Active Moieties can bind to one or multiple targets. For avoidance of doubt, Active Moiety does not include an XTEN Sequence.
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Active Moiety means, with respect to any New Product, the molecules or ions having the chemical structure (the "Base Chemical Structure") which is contained in and is responsible for the physiological or pharmacological action of that New Product. All salts (including salts with hydrogen or coordination bonds), esters, complexes, chelates, clathrates or other such structures which involve the Base Chemical Structure shall be understood to contain such Active Moiety, but such appended portions are not part of the Active Moiety.
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Active Moiety means a molecule, or portion of a molecule, excluding those appended portions of such molecule that cause it to be an ester, salt (including a salt with hydrogen or coordination bonds), or other noncovalent derivative (such as a complex, chelate, or clathrate) of the original or base molecule, responsible for a physiological or pharmacological action of the Licensed Product.
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Related to Active Moiety

  • Therapeutic diet means meals served that are soft, low-fat, low-sodium or controlled calorie.

  • ingredient means any substance, including a food additive used in the manufacture or preparation of food and present in the final product, possibly in a modified form;

  • Cannabinoid means any of the chemical compounds that are the active constituents of marijuana.

  • 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”).

  • 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.

  • Position indicating device means a device on dental X-ray equipment used to indicate the beam position and to establish a definite source-surface (skin) distance. It may or may not incorporate or serve as a beam-limiting device.

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

  • Biological product means a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein other than a chemically synthesized polypeptide, or analogous product, or arsphenamine or any derivative of arsphenamine or any other trivalent organic arsenic compound, applicable to the prevention, treatment, or cure of a disease or condition of human beings.

  • Edible cannabis product means cannabis product that is intended to be used, in whole or in part, for human consumption, including, but not limited to, chewing gum, but excluding products set forth in Division 15 (commencing with Section 32501) of the Food and Agricultural Code. An edible cannabis product is not considered food, as defined by Section 109935 of the Health and Safety Code, or a drug, as defined by Section 109925 of the Health and Safety Code.

  • Opioid antidote means any drug, regardless of dosage amount or method of administration, which has been approved by the United States Food and Drug Administration (FDA) for the treatment of an opioid overdose. “Opioid antidote” includes, but is not limited to, naloxone hydrochloride, in any dosage amount, which is administered through nasal spray or any other FDA-approved means or methods.

  • Active means that the smelter or refiner has committed to undergo an RMAP assessment, completed the relevant documents, and scheduled the on-site assessment. These may be in the pre-assessment, assessment, or corrective-action phases of the assessment.

  • Vaccine means a specially prepared antigen which, upon administration to a person, will result in immunity and, specifically for the purposes of this rule, shall mean influenza and pneumococcal vaccines.

  • Commercial cannabis activity means the production, cultivation,