title: Workshop report: Crystal City V--quantitative bioanalytical method validation and implementation: the 2013 revised FDA guidance.
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.affiliation: U.S. Food and Drug Administration, Silver Spring, MD, USA.
authors.forename: Brian
authors.initials: B
authors.lastname: Booth
authors.forename: Mark E
authors.initials: ME
authors.lastname: Arnold
authors.forename: Binodh
authors.initials: B
authors.lastname: DeSilva
authors.forename: Lakshmi
authors.initials: L
authors.lastname: Amaravadi
authors.forename: Sherri
authors.initials: S
authors.lastname: Dudal
authors.forename: Eric
authors.initials: E
authors.lastname: Fluhler
authors.forename: Boris
authors.initials: B
authors.lastname: Gorovits
authors.forename: Sam H
authors.initials: SH
authors.lastname: Haidar
authors.forename: John
authors.initials: J
authors.lastname: Kadavil
authors.forename: Steve
authors.initials: S
authors.lastname: Lowes
authors.forename: Robert
authors.initials: R
authors.lastname: Nicholson
authors.forename: Marie
authors.initials: M
authors.lastname: Rock
authors.forename: Michael
authors.initials: M
authors.lastname: Skelly
authors.forename: Lauren
authors.initials: L
authors.lastname: Stevenson
authors.forename: Sriram
authors.initials: S
authors.lastname: Subramaniam
authors.forename: Russell
authors.initials: R
authors.lastname: Weiner
authors.forename: Eric
authors.initials: E
authors.lastname: Woolf
mesh_terms: D001681:Biological Assay / Q000379:methods* / Q000592:standards; D015415:Biomarkers / Q000032:analysis*; D033161:Government Regulation; D017408:Guidelines as Topic; D006801:Humans; D014481:United States; D014486:United States Food and Drug Administration; D054928:Validation Studies as Topic
chemical_list: D015415:Biomarkers