The FDA considers two products bioequivalent if the 90% CI of the relative mean Cmax, AUC(0-t) and AUC(0-∞) of the test (e.g. generic formulation) to reference (e.g. innovator brand formulation) should be within 80.00% to 125.00% in the fasting state. Although there are a few exceptions, generally a bioequivalent comparison of Test to Reference formulations also requires administration after an appropriate meal at a specified time before taking the drug, a so-called "fed" or "food-effect" study. A food-effect study requires the same statistical evaluation as the fasting study.
Generic pharmaceutical products need to confirm to the same standard of quality, efficacy and safety as required of the originator’s (innovator) product.
The regulatory guidelines were compared on the basis of various parameters involving the clinical conduct of the bioavailability and bioequivalence studies. The comparison made is of benefit to fraternity in Clinical Research Organization and Pharmaceutical Industry as it aids them in understanding the conduct of such studies mentioned in the guidelines in a common platform, this will aid them in conducting the studies according to the requirements of the respective guidelines for the country they filling the ANDA.
Related Journals of Regulatory Requirements in Bioequivalence
Clinical & Experimental Pharmacology, International Journal of BioAnalytical Methods & BioEquivalence Studies, Journal of Bioequivalence & Bioavailability, MOJ Bioequivalence & Bioavailability, Research Journal of Pharmaceutical Sciences, Bioanalytical Methods & Bioequivalence Studies, Asian Journal of Pharmaceutical Care, Enliven: Biosimilars and Bioavailablity, Chemical Speciation & Bioavailability, Pharmaceutical Regulatory Affairs: Open Access, Journal of Molecular Pharmaceutics & Organic Process Research.