14 research outputs found
Analytical and bioanalytical assay challenges to support comparability studies for biosimilar drug development
No full textChallenges of developing and validating immunogenicity assays to support comparability studies for biosimilar drug development
No full textSystematic Verification of Bioanalytical Similarity Between a Biosimilar and a Reference Biotherapeutic: Committee Recommendations for the Development and Validation of a Single Ligand-Binding Assay to Support Pharmacokinetic Assessments
No full text2011 White Paper on Recent Issues in Bioanalysis & Regulatory Findings from Audits and Inspections
No full textThe 5th Workshop on Recent Issues in Bioanalysis was organized by the Calibration and Validation Group (CVG) as a two-day full immersion workshop for contract research organizations, pharmaceutical companies and regulatory agencies to discuss, review, share perspectives, provide potential solutions and agree upon consistent approaches on recent issues in the bioanalysis of both small and large molecules. The foundation of the workshop was based on high quality, better compliance and scientific excellence. As in the previous editions of this significant event, recommendations were suggested and a consensus was achieved among panelists and attendees on topics of interest in the bioanalytical field. This workshop led to the creation of the present 2011 White Paper in Bioanalysis, which aims to provide an authoritative guide that addresses major recent bioanalytical issues and ‘hot’ topics and how to solve them
7th GCC Insights: incurred samples use; fit-for-purpose validation, solution stability, electronic laboratory notebook and hyperlipidemic matrix testing
No full text2014 White Paper on recent issues in bioanalysis: a full immersion in bioanalysis (Part 3 – LBA and immunogenicity)
No full textConference Report: 6th GCC focus on LBA: critical reagents, positive controls and reference standards; specificity for endogenous compounds; biomarkers; biosimilars
No full text
