Bioequivalence means that two proprietary preparations of a drug, when administered in the same dose and by the same route, will have the same bioavailability, duration of action and efficacy.
Bioequivalence means 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
Bioequivalence means, a biological product that (i) is highly similar to the Product notwithstanding minor differences in clinically inactive components; and (ii) has no clinically meaningful differences between the biological product and the Product in terms of the safety, purity, and potency.
Examples of Bioequivalence in a sentence
Bioequivalence has been shown to be in compliance with the requirements of European guidance documents.
Bioequivalence between the powder for oral suspension and tablets has not been investigated in a paediatric population.
Bioequivalence demonstrates that the active ingredient of the proposed generic drug would be present in the blood of a patient to the same extent and for the same amount of time as the branded counterpart.
Bioequivalence is the “absence of significant difference” in the pharmacokinetic profiles of two pharmaceutical products.
Bioequivalence approaches for highly variable drugs and drug products.
More Definitions of Bioequivalence
Bioequivalence means that two medicinal products, which are pharmaceutical equivalents or pharmaceutical alternatives, have similar bioavailability when administered at the same molar dose to the extent that basically the same effect, including efficacy and safety, can be expected,
Bioequivalence means the absence of a significant difference in the bioavailability between two pharmaceutically equivalent products under similar conditions in an appropriately designed study;
Bioequivalence means the absence of a significant difference in the bioavailability between two
Bioequivalence means for purposes of QD Product or BID Product, as applicable, the least square mean ratios (test/reference) for the point estimates of Cmax and AUC (Cmax, AUCt, AUCinf and AUCtau, as applicable) are between 0.8 and 1.25.
Bioequivalence means the similarity of bioavailability between two drugs when compared under the same testing condition.
Bioequivalence means that two products which are pharmaceutically equivalent or pharmaceutical alternatives, and their bioavailabilities, in terms of rate (Cmax and Tmax) and extent of absorption (area under the curve), after administration of the same molar dose under the same conditions, are similar to such a degree that their effects can be expected to be essentially the same
Bioequivalence means 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 becomesavailable at the site of drug action when administered at the same molar dose under similar conditions in an appropriately designed study. Where there is an intentional difference in rate (e.g., in certain extended release dosage forms), certain pharmaceutical equivalents or alternatives may be considered bioequivalent if there is no significant difference in the extent to which the active ingredient or moiety from each product becomes available at the site of drug action. This applies only if the difference in the rate at which the active ingredient or moiety becomes available at the site of drug action is intentional and is reflected in the proposed labeling, is not essential to the attainment of effective body drug concentrations on chronic use, and is considered medically insignificant for the drug.