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Bioanalysis|August 18, 2025
17th GCC Closed Forum: Integrative Bioanalysis, Patient-centric Sampling, Emerging Technologies, Data Integrity, Sample Reconciliation, Discrepancies of ELISpot Data, Cross-validation Harmonization, Ultrasensitive Platforms for ADA Assays, Remote Regulatory Assessments, Shedding Assays by PCR, and Biomarker Tissue AssaysJennifer Zimmer, Mark O'dell, Derrick Johnson, et al.Bioanalysis|December 23, 2014
2014 White Paper on recent issues in bioanalysis: a full immersion in bioanalysis (Part 2 - hybrid LBA/LCMS, ELN & regulatory agencies' input)Dawn Dufield, Hendrik Neubert, Fabio Garofolo, et al.Bioanalysis|October 1, 2019
GCC Consolidated Feedback to ICH on the 2019 ICH M10 Bioanalytical Method Validation Draft GuidelineCorey Nehls, Michael Buonarati, Stephanie Cape, et al.Bioanalysis|October 11, 2013
2013 White Paper on recent issues in bioanalysis: 'hybrid'--the best of LBA and LCMSLauren Stevenson, Fabio Garofolo, Binodh DeSilva, et al.Bioanalysis|April 18, 2025
Recommendations on biomarker assay validation (BAV) in tissues by GCCMoucun Yuan, Aihua Liu, Bin Xu, et al.Bioanalysis|January 25, 2025
2024 White Paper on Recent Issues in Bioanalysis: Three Way-Cross Validation; Urine Clinical Analysis; Automated Methods; Regulatory Queries on Plasma Protein Binding; Automated Biospecimen Management; ELN Migration; Ultra-Sensitivity Mass Spectrometry (<u>Part 1A</u> - Recommendations on Advanced Strategies for Mass Spectrometry Assays, Chromatography, Sample Preparation and BMV/Regulated Bioanalysis <u>Part 1B</u> - Regulatory Agencies' Inputs on Regulated Bioanalysis/BMV)John Wojcik, Timothy Sikorski, Jian Wang, et al.Pageof 2