Workshop Report: Crystal City V—Quantitative Bioanalytical Method Validation and Implementation: The 2013 Revised FDA Guidance
Journal Title: The AAPS Journal - Year 2015, Vol 17, Issue 2
Abstract
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 revised draft BMV Guidance, the AAPS and FDA once again collaborated to convene a two-and-a-half day workshop during early December 2013 in Baltimore, MD, USA. The resulting format embodied extensive open discussion and each thematic session included only brief, concise descriptions by Agency and industry representatives prior to opening the floor discussion. The Workshop was built around four thematic sessions (Common Topics, Chromatographic, Ligand-Binding Assays, and Biomarkers) and a final session with international regulators, concluding with a review of the outcomes and recommendations from the thematic sessions. This Workshop report summarizes the outcomes and includes topics of agreement, those where the FDA will consider the Industry’s perspective, and those where the workshop provided a first open dialogue. This article will be available to the bioanalytical community at http://www.aaps.org/BMV13.
Authors and Affiliations
Brian Booth, Mark E. Arnold, Binodh DeSilva, Lakshmi Amaravadi, Sherri Dudal, Eric Fluhler, Boris Gorovits, Sam H. Haidar, John Kadavil, Steve Lowes, Robert Nicholson, Marie Rock, Michael Skelly, Lauren Stevenson, Sriram Subramaniam, Russell Weiner, Eric Woolf
Keywords
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- DOI 10.1208/s12248-014-9696-2
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