In Vivo vs In Vitro Bioequivalence

In vivo bioequivalence, or simply bioequivalence, is commonly referred to as an evaluation study conducted to establish equality of mostly two oral products such as tablet or capsule. Equality of two products (test vs reference) is established by comparing their blood drug concentration-time (C-t) profiles. The reason for selecting C-t profiles for such comparison is that as therapeutic effects depend on drug concentrations in blood i.e., if two or more products provide similar C-t profiles then they will provide similar therapeutic effects as well, thus they will be considered therapeutically bioequivalent, or simply bioequivalent. [Continue …]

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