Limits of 80%-125% for AUC and 70%-143% for Cmax. What is the impact on bioequivalence studies?

@article{Hauck2001LimitsO8,
  title={Limits of 80%-125% for AUC and 70%-143% for Cmax. What is the impact on bioequivalence studies?},
  author={Walter W. Hauck and Ameeta Parekh and Lawrence J. Lesko and Merrill Li-lin Chen and Roger L Williams},
  journal={International journal of clinical pharmacology and therapeutics},
  year={2001},
  volume={39 8},
  pages={350-5}
}
OBJECTIVE The US Food and Drug Administration (FDA) currently uses bioequivalence (BE) limits for fasting BE studies that are based on the 90% confidence interval for the ratio of difference of the test and reference products Cmax and AUC falling within 80% to 125%. The FDA has also proposed that BE limits be used similarly for AUC and Cmax measurements from fed BE studies. In some cases, regulatory agencies have considered a wider BE limit for Cmax, because of the typically higher variability… CONTINUE READING

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