Effect of Study Design on Sample Size in Studies Intended to Evaluate Bioequivalence of Inhaled Short‐Acting β‐Agonist Formulations

Pharmacodynamic studies that use methacholine challenge to assess bioequivalence of generic and innovator albuterol formulations are generally designed per published Food and Drug Administration guidance, with 3 reference doses and 1 test dose (3‐by‐1 design). These studies are challenging and expen...

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Detalles Bibliográficos
Autores principales: Zeng, Yaohui, Singh, Sachinkumar, Wang, Kai, Ahrens, Richard C.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2017
Materias:
Drug Development
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5901014/
https://www.ncbi.nlm.nih.gov/pubmed/29281130
http://dx.doi.org/10.1002/jcph.1045

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5901014/
https://www.ncbi.nlm.nih.gov/pubmed/29281130
http://dx.doi.org/10.1002/jcph.1045

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