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Two-stage designs versus European scaled average designs in bioequivalence studies for highly variable drugs: which to choose?

Author
Molins, E.; Cobo, E.; Ocaña, J.
Type of activity
Journal article
Journal
Statistics in medicine
Date of publication
2017-12
Volume
36
Number
30
First page
4777
Last page
4788
DOI
https://doi.org/10.1002/sim.7452 Open in new window
Project funding
Grup de Recerca en Bioestadística i Bioinformàtica (GRBIO)
Statistical methods for clinical trials, complex censoring schemes and integrative omics data analysis
Repository
http://hdl.handle.net/2117/114395 Open in new window
URL
http://onlinelibrary.wiley.com/doi/10.1002/sim.7452/pdf Open in new window
Abstract
The usual approach to determine bioequivalence for highly variable drugs is scaled average bioequivalence, which is based on expanding the limits as a function of the within-subject variability in the reference formulation. This requires separately estimating this variability and thus using replicated or semireplicated crossover designs. On the other hand, regulations also allow using common 2 × 2 crossover designs based on two-stage adaptive approaches with sample size reestimation at an inter...
Citation
Molins, E., Cobo, E., Ocaña, J. Two-stage designs versus European scaled average designs in bioequivalence studies for highly variable drugs: which to choose?. "Statistics in medicine", Desembre 2017, vol. 36, núm. 30, p. 4777-4788.
Keywords
Average Bioequivalence (ABE), Highly Variable Drugs (HVD), Reference Scaled Average Bioequivalence (RSABE), Significance Level Adjustment, Two-Stage Designs (TSD)
Group of research
GRBIO - Biostatistics and Bioinformatics Research Group

Participants

  • Molins Lleonart, Eduard  (author)
  • Cobo Valeri, Erik  (author)
  • Ocaña Rebull, Jordi  (author)

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