Bioequivalence of Highly Variable Drugs: A Comparison of the Newly Proposed Regulatory Approaches by FDA and EMA

@article{Karalis2011BioequivalenceOH,
  title={Bioequivalence of Highly Variable Drugs: A Comparison of the Newly Proposed Regulatory Approaches by FDA and EMA},
  author={Vangelis Karalis and Mira Symillides and Panos Macheras},
  journal={Pharmaceutical Research},
  year={2011},
  volume={29},
  pages={1066-1077}
}
To explore the comparative performance of the recently proposed bioequivalence (BE) approaches, FDAs and EMAs, by the FDA working group on highly variable drugs and the EMA, respectively; to compare the impact of the GMR-constraint on the two approaches; and to provide representative plots of % BE acceptance as a function of geometric mean ratio, sample size and variability. Simulated BE studies and extreme GMR versus CV plots were used. Three sequence, three period crossover studies with two… CONTINUE READING

Citations

Publications citing this paper.
Showing 1-10 of 18 extracted citations

Bioequivalence Requirements in Various Global Jurisdictions

AAPS Advances in the Pharmaceutical Sciences Series • 2017
View 3 Excerpts

References

Publications referenced by this paper.
Showing 1-10 of 36 references

Bioequivalence Approaches for Highly Variable Drugs and Drug Products

Pharmaceutical Research • 2007
View 10 Excerpts
Highly Influenced

Regulatory and study conditions for the determination of bioequivalence of highly variable drugs.

Journal of pharmacy & pharmaceutical sciences : a publication of the Canadian Society for Pharmaceutical Sciences, Societe canadienne des sciences pharmaceutiques • 2009
View 4 Excerpts
Highly Influenced

Highly Variable Drugs : Reference - scaled average bioequivalence and sequential design studies

B Davit
2011

On the leveling-off properties of the new bioequivalence limits for highly variable drugs of the EMA guideline.

European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences • 2011
View 1 Excerpt

Basic Variability and impact on design of bioequivalence studies

A. Van Peer
Clin Pharmacol Toxicol • 2010

Comparison of the reference scaled bioequivalence semi-replicate method with other approaches: focus on human exposure to drugs.

European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences • 2009
View 1 Excerpt

Similar Papers

Loading similar papers…