Bioequivalence is 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.
“The FDA guidance is generally applicable to dosage forms intended for oral administration and to non-orally administered drug products in which reliance on systemic exposure measures is suitable for documenting BE.” FDA explains in the guidance ""We believe that the guidance will also be useful when planning BE studies intended to be conducted during the post-approval period for certain changes in an abbreviated new drug application (ANDA).
(1) Under the Federal Food, Drug and Cosmetic Act (FD&C Act, Section 505(j)), generic drug applications must be essentially identical to the drug which they reference, also known as the reference-listed drug (RLD).
(2) Section 505(j)(2)(iv) outlines the basic requirements for conducting bioequivalence studies, and requires ""information to show that the new drug is bioequivalent to the listed drug""-except in cases of a suitability petition-as well as information showing the drug to be of the same pharmacological or therapeutic class, and that it will have the same ""therapeutic effect"" as the RLD. "
Related Journals of FDA Bioequivalence
International Journal of BioAnalytical Methods & BioEquivalence Studies, Journal of Bioequivalence & Bioavailability, Journal of Molecular Pharmaceutics & Organic Process Research, Journal of Pharmaceutical Care & Health Systems, Journal of Pharmacognosy & Natural Products, Chemical Speciation & Bioavailability, Enliven: Biosimilars and Bioavailablity, Research Journal of Pharmaceutical Sciences, Indian Journal of Pharmaceutical Research.