Bioequivalence (BE)
BETwo formulations are bioequivalent if they have comparable rate and extent of absorption (AUC and Cmax within 80-125% of reference). Required for generic drug approval via ANDA.
示例
- Generic vs branded drug
- 90% CI within 80-125%
- Fed vs fasted BE studies
您知道吗？
Two formulations are bioequivalent if they have comparable rate and extent of absorption (AUC and Cmax within 80-125% of reference). Required for generic drug approval via ANDA.