Population_and_individual

Population and individual bioequivalence

Population and individual bioequivalence are used to assess switchability and prescribability. Because individual bioequivalence relies on estimates of within-subject, within-formulation variation, replicated crossover designs are required. This algorithm was developed by Francis Hsuan. Designs that can be appropriately analyzed include but are not limited to the following list, which shows the Sequence (Period) Design.

2 (4) TRTR/RTRT
4 (4) TRTR/RTRT/TRRT/RTTR
4 (2) TT/RR/TR/RT
4 (3) TRT/RTR/TRR/RTT
2 (5) TRRTT/RTTRR
3 (3) TRR/RTR/RRT
2 (3) RTR/TRT
6 (3) TRR/RTT/TRT/RTR/TTR/RRT
2 (4) TRRR/RTTT
6 (4) TTRR/RRTT/TRRT/RTTR/TRRR/RTTT

The algorithm works for balanced and unbalanced data with an equal number of periods in each sequence and one measurement per subject in each period.

Bioequivalence criterion

Computational details