AAPS Workshop Report on ICH M10

Over the last decade, several regulatory guidelines on bioanalytical method validation (BMV) have been issued by regulatory agencies around the world. This has left the bioanalytical community struggling with regional differences in regulatory expectations when preparing for global pharmaceutical su...

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Detalles Bibliográficos
Autores principales: Booth, Brian, Vazvaei, Faye, Fluhler, Eric, Myler, Heather, Woolf, Eric
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2019
Materias:
Meeting Report
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6904406/
https://www.ncbi.nlm.nih.gov/pubmed/31823177
http://dx.doi.org/10.1208/s12248-019-0398-7

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6904406/
https://www.ncbi.nlm.nih.gov/pubmed/31823177
http://dx.doi.org/10.1208/s12248-019-0398-7

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