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Bioanalysis|August 9, 2024
Re-thinking the current paradigm for clinical immunogenicity assessment: an update from the discussion in the European Bioanalysis ForumJoanne Goodman, Kyra J Cowan, Michaela Golob, et al.Journal of Clinical Microbiology|July 29, 2020
Comparison of Molecular Subtyping and Antimicrobial Resistance Detection Methods Used in a Large Multistate Outbreak of Extensively Drug-Resistant Campylobacter jejuni Infections Linked to Pet Store PuppiesLavin A Joseph, Louise K Francois Watkins, Jessica Chen, et al.Bioanalysis|May 17, 2022
2021 White Paper on Recent Issues in Bioanalysis: TAb/NAb, Viral Vector CDx, Shedding Assays; CRISPR/Cas9 & CAR-T Immunogenicity; PCR & Vaccine Assay Performance; ADA Assay Comparability & Cut Point Appropriateness (Part 3 - Recommendations on Gene Therapy, Cell Therapy, Vaccine Assays; Immunogenicity of Biotherapeutics and Novel Modalities; Integrated Summary of Immunogenicity Harmonization)Lina Loo, Shannon Harris, Mark Milton, et al.Bioanalysis|October 11, 2012
2012 white paper on recent issues in bioanalysis and alignment of multiple guidelinesBinodh DeSilva, Fabio Garofolo, Mario Rocci, et al.Bioanalysis|December 24, 2014
2014 White Paper on recent issues in bioanalysis: a full immersion in bioanalysis (Part 3 - LBA and immunogenicity)Lauren Stevenson, Lakshmi Amaravadi, Heather Myler, et al.Bioanalysis|December 16, 2014
2014 White Paper on recent issues in bioanalysis: a full immersion in bioanalysis (Part 1--small molecules by LCMS)Eric Fluhler, Roger Hayes, Fabio Garofolo, 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|December 14, 2019
2019 White Paper On Recent Issues in Bioanalysis: FDA BMV Guidance, ICH M10 BMV Guideline and Regulatory Inputs (Part 2 - Recommendations on 2018 FDA BMV Guidance, 2019 ICH M10 BMV Draft Guideline and Regulatory Agencies' Input on Bioanalysis, Biomarkers and Immunogenicity)Brian Booth, Lauren Stevenson, Renuka Pillutla, 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.Pageof 7