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

Autor
Molins, E.; Cobo, E.; Ocaña, J.
Tipus d'activitat
Article en revista
Revista
Statistics in medicine
Data de publicació
2017-12
Volum
36
Número
30
Pàgina inicial
4777
Pàgina final
4788
DOI
https://doi.org/10.1002/sim.7452 Obrir en finestra nova
Projecte finançador
Grup de Recerca en Bioestadística i Bioinformàtica (GRBIO)
Metodos estadisticos par ensayos clínicos, patrones de censura complejos y analisis integrado de datos omico
Repositori
http://hdl.handle.net/2117/114395 Obrir en finestra nova
URL
http://onlinelibrary.wiley.com/doi/10.1002/sim.7452/pdf Obrir en finestra nova
Resum
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...
Citació
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.
Paraules clau
Average Bioequivalence (ABE), Highly Variable Drugs (HVD), Reference Scaled Average Bioequivalence (RSABE), Significance Level Adjustment, Two-Stage Designs (TSD)
Grup de recerca
GRBIO - Grup de Recerca en Bioestadística i Bioinformàtica

Participants

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