Batch‐to‐batch pharmacokinetic variability confounds current bioequivalence regulations: A dry powder inhaler randomized clinical trial

Current pharmacokinetic (PK) bioequivalence guidelines do not account for batch‐to‐batch variability in study design or analysis. Here we evaluate the magnitude of batch‐to‐batch PK variability for Advair Diskus 100/50. Single doses of fluticasone propionate and salmeterol combinations were administ...

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Detalles Bibliográficos
Autores principales: Burmeister Getz, E, Carroll, KJ, Jones, B, Benet, LZ
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2016
Materias:
Clinical Trial
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5102576/
https://www.ncbi.nlm.nih.gov/pubmed/27037630
http://dx.doi.org/10.1002/cpt.373

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5102576/
https://www.ncbi.nlm.nih.gov/pubmed/27037630
http://dx.doi.org/10.1002/cpt.373

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