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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...
| Autores principales: | , , , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
| Publicado: |
John Wiley and Sons Inc.
2016
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| Materias: | |
| 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 |