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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.
Bioanalysis|January 25, 2025
2024 White Paper on Recent Issues in Bioanalysis: Evolution of Immunogenicity Assessment beyond ADA/NAb; Regulated Genomic/NGS Assays; Hypersensitivity Reactions; Minimum Noise Reduction; False Positive Range; Modernized Vaccine Approaches; NAb/TAb Correlation (PART 3A - Recommendations on Advanced Strategies for Molecular Assays and Immunogenicity of Gene Therapy, Cell Therapy, Vaccine; Biotherapeutics Immunogenicity Assessment & Clinical Relevance PART 3B - Regulatory Agencies' Input on Immunogenicity/Technologies of Biotherapeutics, Gene, Cell & Vaccine Therapies)Omar Tounekti, Sandra Prior, Sarah Wassmer, et al.
Bioanalysis|November 14, 2024
Harmonization of Vaccine Ligand Binding Assays ValidationFrancis Dessy, Ivo Sonderegger, Leslie Wagner, et al.
Bioanalysis|November 7, 2024
Perspective on LC-MS(/MS) for biotherapeutic and biomarker proteins in research and regulated Bioanalysis: a consolidation of more than a decade of experience across the European Bioanalysis Forum community (Part 1: "The What")Amanda Wilson, Mark Jean Gnoth, Nico van de Merbel, et al.
Bioanalysis|November 18, 2024
Green HPLC method for determination of paracetamol and ibuprofen in human plasma: applications to pharmacokineticsSally A Helmy, Heba M ElBedaiwy, Soha Am Helmy, et al.
Bioanalysis|October 16, 2024
Quantifying skin permeation of a novel metformin lotion using modified hydrophilic interaction liquid chromatographyDerek J Maloney, Jianying Zhang, Satyaj Bhargava, et al.
Bioanalysis|October 15, 2024
An immunoassay for the quantification of phosphorylated α-synuclein at serine 129 in human cerebrospinal fluidAchani M Silva, Elizabeth S Hickford, Paul Cutler
Bioanalysis|October 8, 2024
Assessment of mirvetuximab soravtansine immunogenicity in patients with folate receptor alpha-positive ovarian cancerFengying Zhu, Ya-Ping Tu, Callum Sloss, et al.
Bioanalysis|August 5, 2024
A European Bioanalysis Forum recommendation for requiring a context-of-use statement for successful development and validation of biomarker assaysKyra J Cowan, Ulrich Kunz, Peter Blattmann, et al.
Bioanalysis|July 18, 2024
Development and application of a multi-sugar assay to assess intestinal permeabilityNicole A Schneck, Ahmed Moghieb, Claire Teague, et al.
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