When two distinct formulations of the same drug, which obeys a linear pharmacokinetics, are alike in the rate and extent

to which its active product ingredient is absorbed and becomes equally available at the site of action, they are considered bioequivalent and thus assumed to be therapeutically equivalent since this is a function of its pharmacokinetic-pharmacodynamic relationship [18, 23–25]. Moreover, to demonstrate bioequivalence, it is CX-6258 generally accepted that the 90 % confidence interval for the ratio of means of logarithmically transformed AUC and C max should lie within the range of 80–125 %, with no differences in T max evaluated by a non-parametric test on the untransformed values [26, 27]. ESL presents a pharmacokinetic Histone Methyltransferase inhibitor & PRMT inhibitor profile that can be considered linear [19, 28], and our study data revealed that the both formulations of ESL presented similar pharmacokinetic characteristics. The study results show that both ESL formulations are bioequivalent for the rate and extent of absorption. The Selleck Nutlin-3a 90 % confidence intervals were completely contained within the predefined bioequivalence criteria of 80–125 % for C max and AUC. In general, ESL formulations were well tolerated at both doses (400 and 800 mg) and formulations (MF and TBM) tested, and the observed adverse events were typical

of previous studies of ESL conducted in healthy subjects. 5 Conclusion Oral tablet formulations of either 400 or 800 mg ESL from the new API source was found to be bioequivalent to the corresponding marketed Zebinix® formulation according to the regulatory definition of bioequivalence. Acknowledgments We confirm that we have read the Journal’s position on issues involved in ethical publication and affirm that this report is consistent with those guidelines. This study was sponsored by BIAL-Portela & Co., SA. Disclosure This study was sponsored by BIAL-Portela & Co., SA. All authors were involved in the design or conduct of the study, the collection, management or analysis of the data, and the preparation or review of the manuscript. Dr. Falcão received consultancy

honoraria from BIAL-Portela & Co., SA. Drs. Lima, Sousa, Nunes and Soares-da-Silva are or were employees of BIAL at the time of the Ergoloid study. Conflict of interest None. Open AccessThis article is distributed under the terms of the Creative Commons Attribution Noncommercial License which permits any noncommercial use, distribution, and reproduction in any medium, provided the original author(s) and the source are credited. References 1. Benes J, Parada A, Figueiredo AA, Alves PC, Freitas AP, Learmonth DA, et al. Anticonvulsant and sodium channel-blocking properties of novel 10,11-dihydro-5H-dibenz[b,f]azepine-5-carboxamide derivatives. J Med Chem. 1999;42(14):2582–7.PubMedCrossRef 2. Hainzl D, Parada A, Soares-da-Silva P.