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
Related Articles
- EP ID EP90272
- DOI -
- Views 194
- Downloads 0
A REVIEW ON PENICILLIN ALLERGIES
Penicillin allergies are the most common miss diagnosed and wrongly diagnosed allergies in children. Many children are labeled penicillin allergic without getting them tested prior. Misdiagnosis of penicillin allergy may...
CURCUMIN – A SALUBRIOUS ASSET TO IMMUNE SYSTEM
Ayurveda is the holistic and philosophical system of medicine which has been developed over thousands of years with usage of different types of herbs to cure diseases and ailments. India is the home of Ayurveda promotes...
THE PHARMACOLOGICAL IMPORTANCE OF AILANTHUS ALTISSIMA- A REVIEW
Ailanthus altissima contained proteins, flavonoids, alkaloids, quassinoids, terpenylated coumarins, tetracyclic triterpenoids, fatty acids, volatile oils and many other active compounds. It exerted antibacterial, antivir...
NANOSUSPENSIONS TECHNOLOGY IN DRUG DELIVERY – A REVIEW
Nanosuspensions is colloidal dispersions of nanosized drug particles stabilized by surfactants. They can also be defined as a biphasic system consisting of pure drug particles dispersed in an aqueous vehicle in which the...
EVALUATION OF ANTIULCER ACTIVITY OF PROSOPIS JULIFLORA ETHANOL EXTRACT IN ETHANOL INDUCED GASTRIC ULCERATION IN RATS
There has been much interest in herbal medicines derived from the traditional knowledge of plant pharmacology for treatment of ulcer as there are fewer side effects. In the current study the plant Prosopis juliflora com...