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Evaluation of a Scenario in Which Estimates of Bioequivalence Are Biased and a Proposed Solution: t(last) (Common)

In bioequivalence (BE) testing, it is the convention to identify t(last) separately for each concentration‐vs‐time profile. Within‐subject differences in t(last) between treatments can arise when assay sensitivity is reached during washout, causing profiles to fall below the limit of quantitation (L...

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Detalles Bibliográficos
Autores principales: Fisher, Dennis, Kramer, William, Burmeister Getz, Elise
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2015
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5064724/
https://www.ncbi.nlm.nih.gov/pubmed/26479406
http://dx.doi.org/10.1002/jcph.663