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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
Publicado en:AAPS J
Autores principales: Booth, Brian, Vazvaei, Faye, Fluhler, Eric, Myler, Heather, Woolf, Eric
Formato: Artigo
Lenguaje:Inglês
Publicado: Springer International Publishing 2019
Materias:
Acceso en línea:https://ncbi.nlm.nih.gov/pmc/articles/PMC6904406/
https://ncbi.nlm.nih.gov/pubmed/31823177
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1208/s12248-019-0398-7
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