220-Dictionary of Pharmaceutical Medicine, 2nd Edition-Gerhard Nahler Annette Mollet-3211898352-S

16biolent; FDA: “bioequivalent drug products means pharmaceuticalequivalents or pharmaceutical alternatives whose rate andextent of absorption do not show a significant difference whenadministered at the same molar dose of the therapeutic moiety undersimilar experimental conditions, either single dose or multipledose”; → see also drug comparability study, biologic equivalent,pharmaceutical equivalent, rule 80/125, therapeuticequivalent.bioinformatics The discipline encompassing the development andutilization of computational facilities to store, analyze and interpretbiological data.biologic equivalent Dosage form that results in similar bioavailabilityregardless of the pharmaceutical formulation; → seealso essentially similar product, pharmaceutical equivalent,therapeutic equivalent.biological medicinal products Products such as vaccines, serums,toxins, allergen products and medicinal products derived fromhuman blood or plasma; → see also biopharmaceutical, establishmentlicence application.biological products Clinical trials with blood or biological productsas well as their registration are subject to special regulations in orderto assure absence of infectious contaminants (e.g. mandatoryscreening of blood donors).biological rhythm → see chronotherapy.biomarker Def (NIH): “characteristic that is objectively measuredand evaluated as an indicator of biologic processes, pathogenicprocesses or pharmacological response to a therapeutic intervention”;→ see also surrogate.biopharmaceutical Therapeutic product involving biotechnology,e.g. genetic engineering; product of biotechnological origin suchas antisense, genetic engineering, transgenics, involving manipulationof living organisms; → see also biological medicinalproduct, biotechnology.biorepository → see biobank.biotechnology (Biotech) Development of products by a biologicalprocess. Production may be carried out by using intact organisms,such as yeasts and bacteria, or by using natural substances (e.g. enzymes)from organisms; techniques involving manipulation of livingorganisms or substances made by living organisms, particularlyat the molecular genetic level; according to the U.S. Office of Scienceand Technology Policy, the term covers also “recently developedand newly emerging genetic manipulation techniques, such as recombinantDNA (rDNA), recombinant RNA (rRNA), and cell fusion,that are sometimes referred to as genetic engineering”; → see also