A comparison of the Two One-Sided Tests Procedure and the Power Approach for assessing the equivalence of average bioavailability

@article{Schuirmann2005ACO,
  title={A comparison of the Two One-Sided Tests Procedure and the Power Approach for assessing the equivalence of average bioavailability},
  author={Donald J. Schuirmann},
  journal={Journal of Pharmacokinetics and Biopharmaceutics},
  year={2005},
  volume={15},
  pages={657-680}
}
  • Donald J. Schuirmann
  • Published 1 December 1987
  • Mathematics
  • Journal of Pharmacokinetics and Biopharmaceutics
The statistical test of the hypothesis of no difference between the average bioavailabilities of two drug formulations, usually supplemented by an assessment of what the power of the statistical test would have been if the true averages had been inequivalent, continues to be used in the statistical analysis of bioavailability/bioequivalence studies. In the present article, this Power Approach (which in practice usually consists of testing the hypothesis of no difference at level 0.05 and… 
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