Active Metabolite definition

Active Metabolite means a drug that is processed by the body into an altered form which effects the body.
Active Metabolite means any chemical entity, whose detection and structure are demonstrable to the satisfaction of reviewers at either the US FDA or the Journal of Medicinal Chemistry, that is derived from a Compound after administration of a Compound to humans, provided that such derived chemical entity both retains specific biological activity in an assay in which the compound is active and is produced in sufficient quantity in humans after administration of a Compound to humans such that the arithmetic result of the biological activity of the active metabolite multiplied by the levels achieved in human plasma is at least [...***...] percent ([...***...]%) of the result of a similar arithmetic operation applied to a Compound or Prodrug. Furthermore, a derived chemical entity is an Active Metabolite only if it retains [...***...] of the structural integrity (atoms and their covalent bonds) of the Compound.

Examples of Active Metabolite in a sentence

  • Interaction of the Active Metabolite of Prasugrel, R-138727, with Cysteine 97 and Cysteine 175 of the Human P2Y12 Receptor.

  • Prior to the determination of whether a metabolite is an Active Metabolite or an Inactive Metabolite, Anadys shall be free to synthesize and characterize all metabolites for the purpose of full structural characterization and determination of activity.

  • Comparative Physicochemical and Pharmacokinetic Properties of Quetiapine and Its Active Metabolite Norquetiapine.

  • Lee, H.O. Shim, H.S. Lee, Simultaneous Determination of Losartan and Active Metabolite EXP3174 in Rat Plasma by HPLC with Column Switching H.

  • Development and Application of a Mechanistic Pharmacokinetic Model for Simvastatin and its Active Metabolite Simvastatin Acid Using an Integrated Population PBPK Approach.

  • Inhibition of HIV Replication by A77 1726, the Active Metabolite of Leflunomide, in Combination with Pyrimidine Nucleoside Reverse Transcriptase Inhibitors.

  • Pharmacodynamics Of PNU-100480 (U, Sutezolid), A New Oxazolidinone, In Combination With Its Active Metabolite In The Killing Of Mycobacterium tuberculosis (Mtb) In An in vitro Hollow Fiber Infection Model (HFIM).

  • Calcitriol, the Active Metabolite of Vitamin D3, Inhibits Dry Eye Related Corneal Inflammation In Vivo and In Vitro.

  • Active Metabolite of vitamin D3 (1α,25(OH)2D3) is thought to have an anti -oncogenic effect .

  • Optimal Sampling Strategies for Irinotecan (CPT-11) and Its Active Metabolite (SN-38) in Cancer Patients.

Related to Active Metabolite

  • Isomer means all enantiomers and diastereomers.

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

  • 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;

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

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

  • Corrosion inhibitor means a substance capable of reducing the corrosivity of water toward metal plumbing materials, especially lead and copper, by forming a protective film on the interior surface of those materials.

  • 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)).

  • Inherited Metabolic Disorder means a disease caused by an inherited abnormality of body chemistry that meets all of the following requirements:

  • Licensed Compound means [***].

  • Active Ingredient means the clinically active material(s) that provide pharmacological activity in a pharmaceutical product (excluding formulation components such as coatings, stabilizers, excipients or solvents, adjuvants or controlled release technologies).

  • Nicotine product means a product that contains nicotine and is not any of the following:

  • 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.

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

  • Total tetrahydrocannabinol means the same as that term is defined in § 3.2-4112.

  • Aerosol coating product means a pressurized coating product containing pigments or resins that dispenses product ingredients by means of a propellant, and is packaged in a disposable can for hand-held application, or for use in specialized equipment for ground traffic/marking applications.

  • 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.

  • Milk product or "dairy product" means cottage cheese, dry curd cottage cheese, reduced fat cottage cheese, lowfat cottage cheese, cream, light cream, light whipping cream, heavy cream, heavy whipping cream, whipped cream, whipped light cream, sour cream, acidified sour cream, cultured sour cream, half-and-half, sour half-and-half, acidified sour half-and-half, cultured sour half-and-half, reconstituted or recombined milk and milk products, concentrated milk, concentrated milk products, skim milk, lowfat milk, frozen milk concentrate, flavored milk, eggnog, buttermilk, cultured milk, cultured lowfat milk, cultured skim milk, yogurt, lowfat yogurt, nonfat yogurt, acidified milk, acidified lowfat milk, acidified skim milk, low-sodium milk, low-sodium lowfat milk, low-sodium skim milk, lactose-reduced milk, lactose-reduced lowfat milk, lactose-reduced skim milk, aseptically processed and packaged milk, milk products with added safe and suitable microbial organisms, and any other milk product made by the addition or subtraction of milkfat or addition of safe and suitable optional ingredients for protein, vitamin, or mineral fortification. Unless a product is considered a milk product under this subdivision, milk product does not include dietary products, infant formula, ice cream or other desserts, cheese, or butter. Milk products include the following:

  • Reference biological product means the single biological product licensed pursuant to 42 U.S.C.

  • 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.

  • Cannabinoid extract means a substance obtained by separating cannabinoids from marijuana by:

  • Opioid antagonist means a drug that binds to opioid

  • Cannabinoid edible means food or potable liquid into which a cannabinoid concentrate, cannabinoid extract or dried marijuana leaves or flowers have been incorporated.

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

  • Compounds means any or all of the following chemicals, as the context requires:

  • Grab sample means an individual sample collected in less than 15 minutes in conjunction with an instantaneous flow measurement.