Bioavailability and Bioequivalence


Bioavailability is the degree and rate at which a substance (such as a drug) is absorbed into a living system or is made available at the site of physiological activity. Bioavailability is an essential measurement tool since it determines the correct dosage for non-intravenous administration of a drug. In clinical research trials, the bioavailability of a drug is a key factor to be measured in Phase 1 and Phase 2 trials


Bioequivalence is the property wherein two drugs with identical active ingredients or two different dosage forms of the same drug possess similar bioavailability and produce the same effect at the site of physiological activity. Bioequivalence is determined by pharmacokinetic studies to determine whether a commercially available brand product and a potential to market generic version share core attributes. Determining the absolute bioavailability of a drug is done through a pharmacokinetic study.


 



 


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