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Definition of bioequivalence in English English dictionary
- A measure of the equivalence of multiple formulations of a drug in terms of bioavailability
- Bioequivalence is a term in pharmacokinetics used to assess the expected in vivo biological equivalence of two proprietary preparations of a drug. If two products are said to be bioequivalent it means that they would be expected to be, for all intents and purposes, the same
- The scientific basis upon which brand-name drugs are compared to their generic equivalents Studies must be conducted to ensure the two products do not differ in safety, efficacy, and bioavailability when administered at the same dosages These studies are conducted under the protocols of an ANDA, Abbreviated New Drug Application that is filed with the FDA Product/Service Category: Lab Services: Sub Category: Biological Testing Suggested Reading: Purification of Laboratory Chemicals, Drug Safety Assessment in Clinical Trials Suggested Trade and Journal Publications: American Biotechnology Laboratory, Cell, Drug Discovery & Development, Nature-Biotechnology Pharmaceutical Laboratory
- is the Food & Drug Administration requirement that the active ingredient of a generic drug be absorbed into the body and metabolized in approximately the same amount over approximately the same period as the active ingredient of the innovator drug Bio-equivalence is demonstrated in two ways Dissolution testing determines if the generic drug product dissolves in approximately the same amount of time as the innovator product Blood-level testing is done by giving the generic drug product to humans and measuring how much of the drug enters the bloodstream, how fast it does so, and how long it takes to leave the body
- The scientific basis on which generic and brand-name drugs are generally compared To be considered bioequivalent, the bioavailability and general effects of two products must not differ significantly when the two products are given in studies at the same dosage under similar conditions
- The absence of a significant difference in the rate and extent to which the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes available at the site of drug action when administered at the same molar dose under similar conditions in an appropriately designed study
- Scientific basis on which generic and brand-name drugs are compared To be considered bioequivalent, the bioavailability of two products must not differ significantly when the two products are given in studies at the same dosage under similar conditions Some drugs, however, are intended to have a different absorption rate FDA may consider a product bioequivalent to a second product with a different rate of absorption if the difference is noted in the labeling and doesn't affect the drug's safety or effectiveness or change the drug's effects in any medically significant way