Discover how UPLC-MS/MS can be used to measure purine metabolites and how this may contribute to differential diagnosis of HBV-I and HCC in this research article from Bioanalysis.
Part three of the White Paper published in Bioanalysis from the 2019 13th Workshop on Recent Issues in Bioanalysis (WRIB) covers the FDA immunogenicity guidance, gene therapy, critical reagents, biomarkers and flow cytometry validation.
In this article from Bioanalysis, researchers investigated an electromembrane extraction method for weakly basic benzodiazepines. Results from the electromembrane extraction method followed by UHPLC-MS/MS analysis for human plasma samples were in compliance with EMA guidelines.
Learn more about the highly sensitive immunoassay designed to detect baseline VEGF-A levels in this research article from Bioanalysis.
Part two of the White Paper published in Bioanalysis from the 2019 13th Workshop on Recent Issues in Bioanalysis (WRIB) covers the FDA BMV guidance and the ICH M10 BMV Guideline and Regulatory inputs.
It is documented that soluble drug targets in clinical study samples have generated false positive results in anti-drug antibody bridging assays due to target-mediated bridging. In this research paper read about strategies to mitigate target interference.
Part one of the White Paper published in Bioanalysis from the 2019 13th Workshop on Recent Issues in Bioanalysis (WRIB) covers the use of chromatographic assays in bioanalysis.
In this research article from Bioanalysis learn more about the immunogenicity of anti-body drug conjugates. The research follows eight molecules across 11 clinical trials to evaluate the potentially increased immunogenicity risk of these multi-domain biotherapeutics compared with monoclonal antibodies.
Learn about the development of a robust HPLC-MS/MS method to determine the concentration of everolimus in the eye aqeuous humor and the future outlook for further research in this research article from Bioanalysis.
In this perspective article from Bioanalysis the authors explore key considerations when selecting an IS and propose experiments to perform within the method development phase to demonstrate suitability of the IS within the assay prior to validation.