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Bioanalysis|October 8, 2016
2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV) (Part 1 - small molecules, peptides and small molecule biomarkers by LCMS)Eric Yang, Jan Welink, Stephanie Cape, et al.
Bioanalysis|November 18, 2017
2017 White Paper on recent issues in bioanalysis: aren't BMV guidance/guidelines 'Scientific'? (Part 1 - LCMS: small molecules, peptides and small molecule biomarkers)Jan Welink, Eric Yang, Nicola Hughes, et al.
Bioanalysis|January 20, 2021
2020 White Paper on Recent Issues in Bioanalysis: BMV of Hybrid Assays, Acoustic MS, HRMS, Data Integrity, Endogenous Compounds, Microsampling and Microbiome (Part 1 - Recommendations on Industry/Regulators Consensus on BMV of Biotherapeutics by LCMS, Advanced Application in Hybrid Assays, Regulatory Challenges in Mass Spec, Innovation in Small Molecules, Peptides and Oligos)Hendrik Neubert, Stephen C Alley, Anita Lee, et al.
Bioanalysis|February 13, 2026
2025 White Paper on Recent Issues in Bioanalysis: What is the Future of Bioanalytical LIMS? AI/ML Integration in Bioanalysis; Tear Sample Collection; Radiolabeled Mass Balance Studies; Chiral Assays; Bioanalysis of Antibody-Oligonucleotide & Bicycle Drug Conjugates (PART 1A - Recommendations on Mass Spectrometry Assays, Chromatography, Sample Preparation and Regulated Bioanalysis Sampling, Validating, Analyzing & Reporting PART 1B - Regulatory Agencies' Input on Regulated Bioanalysis/BMV)John Wojcik, Mark Qian, Anton I Rosenbaum, 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 (Part 1A - Recommendations on Advanced Strategies for Mass Spectrometry Assays, Chromatography, Sample Preparation and BMV/Regulated Bioanalysis Part 1B - Regulatory Agencies' Inputs on Regulated Bioanalysis/BMV)John Wojcik, Timothy Sikorski, Jian Wang, et al.
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