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.
Sample 1Sample 2Sample 3
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.”
Sample 1Sample 2Sample 3
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.
Sample 1Sample 2Sample 3

Examples of Active Moiety in a sentence

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

  • The foregoing license shall not include a sublicense under the Brusilow License Agreement unless Seller and its Affiliates agree in writing to pay (in addition to any amounts due under subsection (d) below) any royalties that would be due under the Brusilow License Agreement on account of sales of the applicable Active Moiety Product by Seller, its Affiliates, or their sublicensees.

  • 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.

  • For clarity, “Product” does not include any product that combines icosapent ethyl or ethyl eicosapentaenoic acid with any other active pharmaceutical ingredient or Active Moiety.

  • Summary of Effect of Coadministered Drugs on Exposure to Active Moiety (Risperidone + 9-Hydroxy-Risperidone) in Healthy Subjects or Patients with Schizophrenia Coadministered Drug Dosing Schedule Effect on ActiveCoadministered DrugDosing Schedule* Change relative to reference Effect of Risperidone on other drugsLithiumRepeated oral doses of Risperidone (3 mg twice daily) did not affect the exposure (AUC) or peak plasma concentrations (Cmax) of lithium (n=13).

  • Naia has selected, and Amunix agrees, “NB1001”, comprised of the Active Moiety exenatide fused to [ ], as more fully described in Exhibit B, shall be the Licensed Product unless another Licensed Product is designated in accordance with Section 2.5.

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

  • 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.

  • Active Moiety: Active moiety is the part of molecule that is responsible for physiological or pharmacological action of a drug substance.

  • Table 18 Summary of Effect of Coadministered Drugs on Exposure to Active Moiety (Risperidone + 9-Hydroxy-Risperidone) in Healthy Subjects or Patients with SchizophreniaCoadministered DrugDosing ScheduleEffect on ActiveMoiety (Risperidone + 9- Hydroxy-Risperidone (Ratio*)Risperidone Dose RecommendationCoadministered DrugRisperidoneAUCCmax Enzyme (CYP2D6) Inhibitors Fluoxetine20 mg/day2 or 3 mg twice daily1.41.5Re-evaluate dosing.


More Definitions of Active Moiety

Active Moiety means the smallest chemical pharmacophoric element or three dimensional structure responsible for the physiological or pharmacological action of the drug substance.
Sample 1Sample 2Sample 3
Active Moiety has the meaning set forth in Txxxx 00, Xxxxxx Xxxxxx Code of Federal Regulations, § 314.108(a).
Sample 1Sample 2
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.
Sample 1Sample 2
Active Moiety means the molecule or ion responsible for the physiological or pharmacological action of the drug substance, excluding those appended portions of the molecule that cause the drug to be an ester, salt, or other noncovalent derivative of the molecule, as defined in 21 CFR §314.3.
Sample 1
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.
Sample 1
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.
Sample 1

Related to Active Moiety

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

  • inherited metabolic disease means a disease caused by an inherited abnormality of body chemistry for which testing is mandated by law;

  • 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.

  • Therapeutic Product means a health product categorised as a therapeutic product in the First Schedule to the Act;

  • 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.

  • 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.