bioequivalence study definition
bioequivalence study means a study to establish the absence of a statistically significant difference in the rate and extent of absorption of an active ingredient from a pharmaceutical formulation in comparison to the reference formulation having the same active ingredient when administered in the same molar dose under similar conditions;
bioequivalence study means a study to establish the absence of a statistically significant difference in the rate and extent of absorption of an
bioequivalence study shall have the meaning set forth in Section 3.1 of this Agreement.
More Definitions of bioequivalence study
bioequivalence study or "BE Study" means a comparative bioavailability study designed to establish equivalence between a generic medicinal product and a comparator product. Both the clinical and bioanalytical parts of the study must be conducted in Member States;
bioequivalence study means an in vivo pharmacokinetic study to demonstrate Bioequivalence.
bioequivalence study means a study to be carried out by Impax, that is designed to show that the Original Product Manufactured in Impax’s Manufacturing facility in Taiwan is bioequivalent to the Original Product Manufactured in Impax’s Manufacturing facility in Hayward, California. Without limiting the foregoing, the term “Bioequivalence Study” will include any number of such studies to be carried out by Impax which are necessary to establish bioequivalence.
bioequivalence study means, with respect to a Licensed Product, the [***] of such Licensed Product as a Biosimilar to the related Reference Product in a clinical study in healthy volunteers or patients.
bioequivalence study means a special type of study, where two drugs or two sets of formulation of the same drug are compared to show that they have nearly equal bioavailability parameters;