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| DOI | 10.1002/PST.1950 | ||||
| Año | 2019 | ||||
| Tipo | artículo de investigación |
Citas Totales
Autores Afiliación Chile
Instituciones Chile
% Participación
Internacional
Autores
Afiliación Extranjera
Instituciones
Extranjeras
Reference-scaled average bioequivalence (RSABE) approaches for highly variable drugs are based on linearly scaling the bioequivalence limits according to the reference formulation within-subject variability. RSABE methods have type I error control problems around the value where the limits change from constant to scaled. In all these methods, the probability of type I error has only one absolute maximum at this switching variability value. This allows adjusting the significance level to obtain statistically correct procedures (that is, those in which the probability of type I error remains below the nominal significance level), at the expense of some potential power loss. In this paper, we explore adjustments to the EMA and FDA regulatory RSABE approaches, and to a possible improvement of the original EMA method, designated as HoweEMA. The resulting adjusted methods are completely correct with respect to type I error probability. The power loss is generally small and tends to become irrelevant for moderately large (affordable in real studies) sample sizes.
| Ord. | Autor | Género | Institución - País |
|---|---|---|---|
| 1 | Ocana, Jordi | Hombre |
Univ Barcelona - España
Universitat de Barcelona - España |
| 2 | Munoz, Joel | Hombre |
Universidad de Concepción - Chile
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| Fuente |
|---|
| Ministerio de Economía y Competitividad |
| MINECO/FEDER |
| Generalitat de Catalunya |
| Federación Española de Enfermedades Raras |
| Ministerio de EconomÃa y Competitividad |
| Ministerio de Economia y Competitividad (Spain) |
| Agradecimiento |
|---|
| Ministerio de Economia y Competitividad (Spain), Grant/Award Number: Grant MTM2015-64465-C2-1-R (MINECO/FEDER); Generalitat de Catalunya, Grant/Award Number: 2017 SGR 622 |
| This research is partially supported by Grant MTM2015-64465-C2-1-R (MINECO/FEDER) from the Ministerio de Economía y Competitividad (Spain) and by grant 2017 SGR 622 from the Generalitat de Catalunya. The data that support the findings of this study are available from the corresponding author upon reasonable request. These include the data used in the example Section jointly with the R scripts used for the calculations described therein. The simulations code and additional simulation results are also available upon request. |