ICH Guideline for Biopharmaceutics Classification System-Based Biowaiver (M9): Toward Harmonization in Latin American Countries

The biopharmaceutical classification system (BCS) is a very important tool to replace the traditional in vivo bioequivalence studies with in vitro dissolution assays during multisource product development. This paper compares the most recent harmonized guideline for biowaivers based on the biopharma...

Descripción completa

Detalles Bibliográficos
Autores principales: Miranda, Claudia, Aceituno, Alexis, Fernández, Mirna, Mendes, Gustavo, Rodríguez, Yanina, Llauró, Verónica, Cabrera-Pérez, Miguel Ángel
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2021
Materias:
Article
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8001157/
https://www.ncbi.nlm.nih.gov/pubmed/33801796
http://dx.doi.org/10.3390/pharmaceutics13030363

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8001157/
https://www.ncbi.nlm.nih.gov/pubmed/33801796
http://dx.doi.org/10.3390/pharmaceutics13030363

Ejemplares similares