Bioavailability (BA) / Bioequivalence (BE) in Pharma

About this course

Bioavailability (BA) is defined as the rate and extent to which the active ingredient is absorbed from a drug product and becomes available at the site of action. Bioavailability studies provide an estimate of the fraction of drug absorbed as well as drug distribution and elimination. Bioavailability studies are also used to develop a therapeutic dosage regimen.Generic drug products are drug products containing the same active pharmaceutical drug ingredient (API) in the same dosage form as that marketed by the innovator (brand) company. A generic drug product is considered a therapeutic equivalent to the innovator (brand) drug product if it meets the regulatory requirements for therapeutic equivalence. In generic drug development, bioequivalence studies are used to determine bioequivalence.Bioequivalence (BE) is defined as the absence of a significant difference in the rate and extent to which the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes available at the site of drug action when administered at the same molar dose under similar conditions in an appropriately designed study.Bioequivalent drug products are pharmaceutical equivalent or pharmaceutical alternative products that display comparable bioavailability to a reference drug product when studied under similar experimental conditions.The test drug product (generic product) is considered bioequivalent to the reference drug product if the rate and extent of absorption of the test drug does not show a significant difference from the rate and extent of absorption of the reference drug when administered at the same molar dose of the therapeutic ingredient under similar experimental conditions.BIOAVAILABILITY &