Sensitivity of indirect metrics for assessing "rate" in bioequivalence studies--moving the "goalposts" or changing the "game".

@article{RostamiHodjegan1994SensitivityOI,
  title={Sensitivity of indirect metrics for assessing "rate" in bioequivalence studies--moving the "goalposts" or changing the "game".},
  author={Amin Rostami-Hodjegan and Peter R Jackson and Geoffrey T. Tucker},
  journal={Journal of pharmaceutical sciences},
  year={1994},
  volume={83 11},
  pages={1554-7}
}
The requirement to assess "rate" in bioequivalence tests using indirect metrics reinforces ambiguities as to whether such testing is intended to assure both pharmaceutical quality with respect to drug release characteristics as well as clinical safety and efficacy. Using a one-compartment open pharmacokinetic model with first-order absorption and error-free data, the effects of systematically changing the ratio of the absorption rate constants of test and reference formulations on various… CONTINUE READING

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