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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Vydáno v:AAPS J
Hlavní autoři: 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
Médium: Artigo
Jazyk:Inglês
Vydáno: Springer US 2014
Témata:
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On-line přístup: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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