A REVIEW ON THE PROCESS OF SINGLE DOSE CROSSOVER COMPARATIVE ORAL BIOAVAILABILITY STUDIES IN HUMANS
Journal Title: Int J of Pharm Rev& Res - Year 2014, Vol 4, Issue 3
Abstract
Bioavailability (BA) and Bioequivalence (BE) studies play a major role in the drug development phase for both new drug products and their generic equivalents, and thus attract considerable attention globally. Bioequivalence (BE) means the absence of a greater than allowable difference between the systemic bioavailability of a test product and that of a reference product. BA/BE focus on the release of the drug from the dosage form and absorption into the systemic circulation. The value of the testing two one-sided null hypotheses of non-equivalence at a significance level of 0.05, and the importance of estimating a 90% confidence interval of the ratio (test/reference) of mean AUC and Cmax values, and of the difference between mean tmax values, are now reasonable knowledge of the pharmacodynamics and / or pharmacokinetics of the active substance in question. The design and conduct of the study should follow ICH/ EU regulations on Good Clinical Practice, including reference to an Ethics committee. This article briefly reviews the BA/BE concepts, various basic regulatory considerations, design and conduct of BA/ BE studies.
Authors and Affiliations
Devi Sowjanya1 , Ramesh T2 , Ramesh M2 , Vasanth PM1
Keywords
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