In this commentary from Bioanalysis, authors discuss the evolution of bioanalytical method validation guideline language, tracking changes through references to BMV guidance in Bioanalyis journal over the past decade.
Browsing: regulated bioanalysis
John Smeraglia (UCB, Brussels, Belgium) explains how translational biomarkers fit into the bioanalytical landscape and how to select an appropriate analytical methodology when carrying out translational studies.
Internal standards in regulated bioanalysis: putting in place a decision-making process during method development
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.
Novel artificial intelligence tool could revolutionize bioanalytical data review for precision drug development
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.
Find out what regulatory recommendations exist for bioanalytical support of adeno-associated virus gene therapy development in this Bioanalysis article giving an overview of the current regulatory recommendations as found in FDA and EMA guidance documents.
GCC consolidated feedback to ICH on the 2019 ICH M10 bioanalytical method validation draft guideline supplement
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).