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Publicaties

EBF recommendation on practical management of critical reagents for antidrug antibody ligand-binding assays

11th GCC Closed Forum: cumulative stability; matrix stability; immunogenicity assays; laboratory manuals; biosimilars; chiral methods; hybrid LBA/LCMS assays; fit-for-purpose validation; China Food and Drug Administration bioanalytical method validation

EBF recommendation on practical management of critical reagents for PK ligand-binding assays

Incurred sample reproducibility: 10 years of experiences: views and recommendations from the European Bioanalysis Forum

2017 White Paper on recent issues in bioanalysis: a global perspective on immunogenicity guidelines & biomarker assay performance (Part 3-LBA: immunogenicity, biomarkers and PK assays)

Best practices in performing flow cytometry in a regulated environment: feedback from experience within the European Bioanalysis Forum

Method transfer: a CRO perspective

The 10th GCC Closed Forum: rejected data, GCP in bioanalysis, extract stability, BAV, processed batch acceptance, matrix stability, critical reagents, ELN and data integrity and counteracting fraud

Recommendations for the development and validation of flow cytometry-based receptor occupancy assays

Role of receptor occupancy assays by flow cytometry in drug development

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