Some statistical considerations on the FDA draft guidance for individual bioequivalence.

@article{Hsuan2000SomeSC,
  title={Some statistical considerations on the FDA draft guidance for individual bioequivalence.},
  author={Francis Hsuan},
  journal={Statistics in medicine},
  year={2000},
  volume={19 20},
  pages={2879-84}
}
In December of 1997, the FDA proposed a draft guidance for future in vivo bioequivalence studies. The guidance suggested specific criteria for new drug sponsors to show individual bioequivalence (IBE). The criteria use a mixed-scaling aggregate strategy. It has been generally accepted that, under some particular situations, the proposed criteria would result in a relaxation of the current bioequivalence standard set by the average bioequivalence (ABE) criterion. Here we study the magnitude of… CONTINUE READING