Workshop Report: Crystal City V—Quantitative Bioanalytical Method Validation and Implementation: The 2013 Revised FDA Guidance

In September 2013, the FDA released a draft revision of the Bioanalytical Method Validation (BMV) Guidance, which included a number of changes to the expectations for bioanalysis, most notably the inclusion of biomarker assays and data. To provide a forum for an open, inclusive discussion of the rev...

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Detalhes bibliográficos
Publicado no:AAPS J
Main Authors: Booth, Brian, Arnold, Mark E., DeSilva, Binodh, Amaravadi, Lakshmi, Dudal, Sherri, Fluhler, Eric, Gorovits, Boris, Haidar, Sam H., Kadavil, John, Lowes, Steve, Nicholson, Robert, Rock, Marie, Skelly, Michael, Stevenson, Lauren, Subramaniam, Sriram, Weiner, Russell, Woolf, Eric
Formato: Artigo
Idioma:Inglês
Publicado em: Springer US 2014
Assuntos:
White Paper
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC4365089/
https://ncbi.nlm.nih.gov/pubmed/25549614
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1208/s12248-014-9696-2
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