Limits for the Scaled Average Bioequivalence of Highly Variable Drugs and Drug Products

@article{Tothfalusi2003LimitsFT,
  title={Limits for the Scaled Average Bioequivalence of Highly Variable Drugs and Drug Products},
  author={Laszlo Tothfalusi and L{\'a}szl{\'o} Endr{\'e}nyi},
  journal={Pharmaceutical Research},
  year={2003},
  volume={20},
  pages={382-389}
}
Purpose. To provide a rational procedure for establishing regulatory bioequivalence (BE) limits that can be applied in determinations of scaled average BE for highly-variable (HV) drugs and drug products. Methods. Two-period crossover BE investigations with either 24 or 36 subjects were simulated with assumptions of a coefficient of variation of 10, 20, 30, or 40%. The decline in the fraction of accepted studies was recorded as the ratio of geometric means (GMR) for the two formulations was… CONTINUE READING