definiens: means any chemica ! entity, whose detection andstructure are demonstrable to the satisfaction of reviewers < ! leilI, er the USFDA or the Journal of Medicinal Chemistry, that is derived from a Compoundafter administration of a Compoulld to humans, provided that such deri vellchemical entity both retains specific biological activity in an assay in wmchthe compound is active and is produced in sufficient quantity in humans afte!"administration of a Compound to humans such that the arithmetic result of thebiological activity of the active metabolite multiplied by the levels achieved inhuman plasma is at least five percent ( 5 % ) of the result of a similar arithmetic ' * ' operation applied to a Compound or Prodrug . Furthermore, a derivedchemical entity is an Active Metabolite only if it retains the majority of the ~structural integrity ( atoms and their covalent bonds ) of the Compound