| bioequivalence |
Scientific basis on which generic and brand-name drugs are compared. To be considered bioequivalent, the bioavailability of two products must not differ significantly when the two products are given in studies at the same dosage under similar conditions. Some drugs, however, are intended to have a different absorption rate. ...
출처: www.fda.gov/fdac/special/newdrug/bengloss.html
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| bioequivalence |
Bioequivalence means 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.
출처: www.sotret.com/glossary.asp
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| bioequivalence |
is the Food & Drug Administration requirement that the active ingredient of a generic drug be absorbed into the body and metabolized in approximately the same amount over approximately the same period as the active ingredient of the innovator drug. Bio-equivalence is demonstrated in two ways. Dissolution testing determines if the generic drug product dissolves in approximately the same amount of time as the innovator product. ...
출처: pubs.acs.org/cen/coverstory/8038/8038biogenerics2a...
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