Therapeutic equivalents definition

Therapeutic equivalents means chemical equivalents which, when administered to the same individuals in the same dosage regimen, will provide essentially the same efficacy or toxicity as their respective reference drug products.
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Therapeutic equivalents means chemical equivalents
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Therapeutic equivalents means the use of nutriceuticals or any other non-legend agents or modalities of treatment that possess the same or greater efficacy as allopathic medications or conventional treatments.
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Examples of Therapeutic equivalents in a sentence

  • Therapeutic equivalents of contraceptive drugs, devices or products that are approved by the United States Food and Drug Administration.

  • Therapeutic equivalents do not include therapeutic substitutions.

  • Therapeutic equivalents can be expected to have the same clinical effect and safety profile when administered to patients under the conditions specified in the labeling.”43 Pharmaceutical equivalents are products that contain the same active ingredient in the same strength, dosage form, and route of administration.44 Bioequivalence means that the products are absorbed into the body at a similar rate and extent.45 Interchangeability “is not defined by FDA and could have a number of different meanings.

  • Therapeutic equivalents can be substituted for one another with the expectation that there will be similar clinical effects and that follow- up testing would not be required.

  • Therapeutic equivalents can be expected to have the same clinical effect and safety profile when administered to patients under the conditions specified in the labeling.”37 Pharmaceutical equivalents are products that contain the same active ingredient in the same strength, dosage form, and route of administration.38 Bioequivalence means that the products are absorbed into the body at a similar rate and extent.39 Interchangeability “is not defined by FDA and could have a number of different meanings.

  • Moving the truck into the "OPERATING" position with the low voltage plug disengaged.

  • Thus, the current definition in the Orange Book Preface states: Therapeutic equivalents are approved drug products that are pharmaceutical equivalents for which bioequivalence has been 70 FDA, Orange Book Preface (Feb.

  • Therapeutic equivalents are approved drug products that are pharmaceutical equivalents for which bioequivalence has been demonstrated, and that can be expected to have the same clinical effect and safety profile when administered to patients under the conditions specified in the labeling.

  • Suprabioavailable products cannot claim “essential similarity” (see section 2.5) with the innovator product.APPENDIX I Therapeutic Equivalents Therapeutic equivalents contain the same active substance or therapeutic moiety and, when administered clinically, show the same efficacy/safety as the medicinal product whose efficacy and safety are established (cf 2.6.).

  • Therapeutic equivalents can be expected to have the same clinical effect and safety profile when administered to patients under the conditions specified in the labeling.”35 Pharmaceutical equivalents are products that contain the same active ingredient in the same strength, dosage form, and route of administration.36 Bioequivalence means that the products are absorbed into the body at a similar rate and extent.37 Interchangeability “is not defined by FDA and could have a number of different meanings.


More Definitions of Therapeutic equivalents

Therapeutic equivalents means chemical equivalents which,
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Related to Therapeutic equivalents

  • Therapeutic Equivalent means that a Covered Drug can be expected to produce essentially the same therapeutic outcome and toxicity.

  • Generic Equivalent or "generically equivalent" means a drug that has an identical amount of the same active chemical ingredients in the same dosage form, that meets applicable standards of strength, quality and purity according to the United States pharmacopeia or other nationally recognized compendium and that, if administered in the same amounts, will provide comparable therapeutic effects. Generic equivalent or generically equivalent does not include a drug that is listed by the federal food and drug administration as having unresolved bioequivalence concerns according to the administration's most recent publication of approved drug products with therapeutic equivalence evaluations.

  • Therapeutically equivalent drug products means drug products that contain the same active ingredients and are identical in strength or concentration, dosage form, and route of administration and that are classified as being therapeutically equivalent by the U.S. Food and Drug Administration pursuant to the definition of "therapeutically equivalent drug products" set forth in the most recent edition of the Approved Drug Products with Therapeutic Equivalence Evaluations, otherwise known as the "Orange Book."

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

  • Therapeutic school means a residential group living facility:

  • Morphine equivalent dose means a conversion of various opioids to a morphine equivalent dose by the use of accepted conversion tables.

  • Diagnostic Product means In Vitro Diagnostics, In Vivo Diagnostic Agents and any product used for Diagnosis.

  • Therapeutically equivalent means a drug product with the same efficacy and toxicity when administered to an individual as the originally prescribed drug as provided for in Section 39‑24‑40.

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

  • Marihuana-infused product means a topical formulation, tincture, beverage, edible substance, or similar product containing marihuana and other ingredients and that is intended for human consumption.

  • Biosimilar Product means, with respect to a Licensed Product in any country, any biosimilar product sold by a Third Party not authorized by or on behalf of Celgene, its Affiliates or Sublicensees, (a) that is a biosimilar biological product, as defined in 21 USC 379j-51 (or any successor or replacement thereof), a similar biological medicinal product, as defined in Annex I to Directive 2001/83/EC (or any successor or replacement thereof), or any similar biosimilar or generic product under the Laws of any country or jurisdiction, or (b) regarding which Regulatory Approval is obtained by referencing Regulatory Data of such Licensed Product.

  • Combination Products means any product containing both a pharmaceutically active agent or ingredient which constitutes a Licensed Product and one or more other pharmaceutically active agents or ingredients which do not constitute Licensed Products.

  • Diagnostic x-ray system means an x-ray system designed for irradiation of any part of the human or animal body for the purpose of diagnosis or visualization.

  • Domestic Animal means any animal which is tamed or which has been or is being sufficiently tamed to serve some purpose for the use of man or which, although it neither has been nor is intended to be so tamed, is or has become in fact wholly or partly tamed-,

  • Combination Product means (a) a product containing a Licensed Product together with one or more other active ingredients that have independent biologic or chemical activity when present alone that are sold as a single unit, or (b) a Licensed Product together with one or more products, devices, pieces of equipment or components thereof, that are sold as a single package at a single price.

  • Alternative nicotine product means any vaping product, whether or not it includes nicotine, including electronic smoking devices, that can be ingested into the body by chewing, smoking, absorbing, dissolving, inhaling, or by any other means. ‘Alternative nicotine product’ does not include:

  • Aluminum equivalent means the thickness of type 1100 aluminum alloy affording the same attenuation, under specified conditions, as the material in question.

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

  • Existing Product means any formulation of the same product category and form sold, supplied, manufactured, or offered for sale in California prior to the following dates, or any subsequently introduced identical formulation:

  • Radiopharmaceutical means any drug that exhibits spontaneous disintegration of unstable nuclei with the emission of nuclear particles or photons and includes any non-radioactive reagent kit or radionuclide generator that is intended to be used in the preparation of any such substance, but does not include drugs such as carbon-containing compounds or potassium-containing salts that include trace quantities of naturally occurring radionuclides. The term also includes any biological product that is labeled with a radionuclide or intended solely to be labeled with a radionuclide.

  • Marijuana-infused products means products that contain marijuana or marijuana extracts and are intended for human use. The term "marijuana-infused products" does not include useable marijuana.

  • Licensed Compounds means any EZH2 Compound(s) that is:

  • Diagnostic mammography means a method of screening that

  • 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.

  • Licensed Product means any method, process, composition, product, service, or component part thereof that would, but for the granting of the rights set forth in this Agreement, infringe a Valid Claim contained in the Licensed Patents.

  • Licensed Compound means (a) 3,4-Diaminopyridine, the chemical structure of which is set forth on Exhibit B-2; and (b) any derivatives, isomers, metabolites, prodrugs, acid forms, base forms, salt forms, or modified versions of such compound in (a).