Between‐Batch Pharmacokinetic Variability Inflates Type I Error Rate in Conventional Bioequivalence Trials: A Randomized Advair Diskus Clinical Trial

We previously demonstrated pharmacokinetic differences among manufacturing batches of a US Food and Drug Administration (FDA)‐approved dry powder inhalation product (Advair Diskus 100/50) large enough to establish between‐batch bio‐inequivalence. Here, we provide independent confirmation of pharmaco...

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Detalles Bibliográficos
Publicado en:Clin Pharmacol Ther
Autores principales: Burmeister Getz, E, Carroll, KJ, Mielke, J, Benet, LZ, Jones, B
Formato: Artigo
Lenguaje:Inglês
Publicado: John Wiley and Sons Inc. 2016
Materias:
Clinical Trial
Acceso en línea:https://ncbi.nlm.nih.gov/pmc/articles/PMC5324827/
https://ncbi.nlm.nih.gov/pubmed/27727445
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1002/cpt.535
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