bioequivalence trial

A mandatory trial, conducted under an abbreviated new drug (ANDA) trial filed with the FDA, based on 20 to 40 healthy subjects, to ensure that the 2 products being evaluated do not differ in safety and efficacy and compare the bioavailability when administered at the same dosages.
Examples, summary measures
A BT records pharmacokinestic measures, but does not assess, clinical improvement or lack thereof. In a BT, summary measures of the plasma concentration vs time profile are used to compare 2 formulations of a drug product; equivalence of area under the curve (AUC), maximum plasma concentration (Cmax) and time to maximum concentration (Tmax) summary measures, does not guarantee equivalence of the entire profile.

单词	bioequivalence trial
释义	bioequivalence trial bioequivalence trial A mandatory trial, conducted under an abbreviated new drug (ANDA) trial filed with the FDA, based on 20 to 40 healthy subjects, to ensure that the 2 products being evaluated do not differ in safety and efficacy and compare the bioavailability when administered at the same dosages. Examples, summary measures A BT records pharmacokinestic measures, but does not assess, clinical improvement or lack thereof. In a BT, summary measures of the plasma concentration vs time profile are used to compare 2 formulations of a drug product; equivalence of area under the curve (AUC), maximum plasma concentration (Cmax) and time to maximum concentration (Tmax) summary measures, does not guarantee equivalence of the entire profile.
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