Between-Batch Bioequivalence (BBE): a Statistical Test to Evaluate In Vitro Bioequivalence Considering the Between-Batch Variability

Bioequivalence testing is an essential step during the development of generic drugs. Regulatory agencies have drafted recommendations and guidelines to frame this step but without finding any consensus. Different methodologies are applied depending on the geographical region. For instance, in the EU...

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Detalles Bibliográficos
Autores principales: Bodin, Jonathan, Liandrat, Stéphanie, Kocevar, Gabriel, Petitcolas, Céline
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2020
Materias:
Research Article
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7651657/
https://www.ncbi.nlm.nih.gov/pubmed/32910283
http://dx.doi.org/10.1208/s12248-020-00486-5

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7651657/
https://www.ncbi.nlm.nih.gov/pubmed/32910283
http://dx.doi.org/10.1208/s12248-020-00486-5

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