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According to regulations applicable in the European Economic Area [EEA] two medical products are bioequivalent if they are pharmaceutically identical or pharmaceutical options and if their bioavailabilities after administration in the same molar dose are equivalent to such a degree or extent that their effects, with respect to efficacy and safety, will be essentially the same. This is considered demonstrated if the 90% confidence intervals (90% CI) of the ratios for AUC0-t and Cmax between the two preparations lie in the range 80.00 – 125.00%.
the revised European Union (EU) Guideline on the Investigation of Bioequivalence and to discuss critically with respect to previous European requirements and present US Food and Drug Administration guidelines its more relevant novelties such as the following: in order to facilitate the development of generic medicinal products, the EU guideline includes the eligibility for Biopharmaceutics Classification System (BCS)-based biowaivers not only for BCS class I drugs but also for class III drugs with tighter requirements for dissolution and excipient composition.
The guideline also specifies that the statistical analyses should be performed considering all factors as fixed, which has implications in the case of replicate designs.
Related Journals of European Bioequivalence
Journal of Biomedical and Pharmaceutical Research, International Journal of BioAnalytical Methods & BioEquivalence Studies, Journal of Bioequivalence & Bioavailability, MOJ Bioequivalence & Bioavailability, Journal of Pharmaceutical Science and Research, Bioanalytical Methods & Bioequivalence Studies, Enliven: Biosimilars and Bioavailablity, Chemical Speciation & Bioavailability, Cardiovascular Pharmacology: Open Access, Journal of Molecular Pharmaceutics & Organic Process Research.