Bioavailability and Bioequivalence Studies

Bioavailability and Bioequivalence are designed to FDA evaluation of the safety and effectiveness of a product .BA for a given formulation provides an estimate of the relative fraction of the orally 94 administered doses that is absorbed into the systemic circulation. Bioavailability and Bioequivalence mainly focus on the release of a drug substance from a drug. Several in-vitro and in-vivo methods are used to measure the bioavailability of the drugs. For BA and BE studies a single-dose, fasting study be performed. BA studies provide other useful pharmacokinetic information related to distribution, elimination, the effects of nutrients on absorption of the drug, dose proportionality, linearity in pharmacokinetics of the active moieties and, where appropriate, inactive moieties.

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