J Psychosoc Nurs Men
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J Psychosoc Nurs Men · Jan 2010
Evaluating the bioavailability and bioequivalence of generic medications.
By law, the U. S. Food and Drug Administration (FDA) is permitted to approve generic versions of brand-name medications without necessarily requiring that research be conducted to prove them safe and effective, provided that a number of criteria are met. ⋯ Bioequivalence means that there is an equivalent rate and extent of absorption of the same active ingredient from two or more drug products. For a generic drug to be approved, both Cmax and AUC must vary only within a certain limited range compared with those for the brand name medication. Information about generic and pharmaceutical alternative drugs can be found in the Orange Book and via Drugs@FDA.