In this research article, the authors investigate the differences between two methods for matrix-based stability testing. This article is from the special focus issue published by Bioanalysis on Stability Issues in Bioanalysis.
Trajan Scientific and Medical (Melbourne, Australia) has listed its hemaPEN® blood microsampling device with the US FDA as Class I for therapeutic and in vitro diagnostic use.
In this feature we assess the global bioanalytical landscape in light of the draft ICH M10 bioanalytical method validation guideline published in 2019. Explore the impact of the draft guidance document through a selection of exclusive Bioanalysis journal and Bioanalysis Zone content.
In this supplement from Bioanalysis, the European Bioanalysis Forum reports its feedback to the ICH on the ICH M10 bioanalytical method validation draft guideline gathered during the public consultation period.
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.
Specialist in artificial intelligence-enabled solutions, Ariadne Software (PA, USA), announces the launch of Red Thread™, an innovative tool that could revolutionize bioanalytical data review for precision drug development.
Bioanalysis has published a supplement presenting the Global CRO Council for Bioanalysis’ (GCC) feedback to the 2019 ICH M10 Bioanalytical Method Validation Draft Guideline from the 13th GCC Closed Forum (LA, USA, 5 April 2019).
Rafiq Islam (Celerion) gives us his thoughts on the GCC Consolidated Feedback to ICH on the 2019 ICH M10 Bioanalytical Method Validation Draft Guideline in this interview with Bioanalysis Zone.
Mike Buonarati (Intertek Pharmaceutical Services) gives his thoughts on the GCC Consolidated Feedback to ICH on the 2019 ICH M10 Bioanalytical Method Validation Draft Guideline in this interview with Bioanalysis Zone.
Roger Hayes (ICON plc) gives his thoughts on the GCC Consolidated Feedback to ICH on the 2019 ICH M10 Bioanalytical Method Validation Draft Guideline in this interview with Bioanalysis Zone.
