Active Metabolite definition

Active Metabolite means a drug that is processed by the body into an altered form which effects the body.
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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.
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Examples of Active Metabolite in a sentence

  • 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.

Related to Active Metabolite

  • Isomer means the optical isomer, except as used in

  • 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