Performance of Multiple-Batch Approaches to Pharmacokinetic Bioequivalence Testing for Orally Inhaled Drug Products with Batch-to-Batch Variability

Batch-to-batch pharmacokinetic (PK) variability of orally inhaled drug products has been documented and can render single-batch PK bioequivalence (BE) studies unreliable; results from one batch may not be consistent with a repeated study using a different batch, yet the goal of PK BE is to deliver a...

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Detalles Bibliográficos
Autores principales: Burmeister Getz, Elise, Carroll, Kevin J., Christopher, J. David, Morgan, Beth, Haughie, Scott, Cavecchi, Alessandro, Wiggenhorn, Christopher, Beresford, Hayden, Strickland, Helen, Lyapustina, Svetlana
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2021
Materias:
Research Article
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8376725/
https://www.ncbi.nlm.nih.gov/pubmed/34410557
http://dx.doi.org/10.1208/s12249-021-02063-1

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