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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  • EP ID EP90272
  • DOI -
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How To Cite

Devi Sowjanya1, Ramesh T2, Ramesh M2, Vasanth PM1 (2014). A REVIEW ON THE PROCESS OF SINGLE DOSE CROSSOVER COMPARATIVE ORAL BIOAVAILABILITY STUDIES IN HUMANS. Int J of Pharm Rev& Res, 4(3), 175-182. https://europub.co.uk/articles/-A-90272