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.
In this White Paper from Bioanalysis, the authors discuss the European Bioanalysis Forum’s recommendations for critical reagents (CR) for immunogenicity assays. They present the requirements for CR and describe the consequences of introducing new lots of CR to immunogenicity assays.
In this perspective article from Bioanalysis, the authors discuss the similarities and differences of critical reagents in LBAs and hybrid LC–MS assays. The authors propose that the benefits of well-characterized hybrid LC–MS assay reagents are frequently underestimated.
In this methodology article from Bioanalysis, authors outline the validation of methods for determining pediatric midazolam using wet whole blood and volumetric absorptive microsampling.
In this white paper from Bioanalysis the European Bioanalysis Forum reflect on the implementation and use of incurred sample reanalysis as an integrated part of regulated bioanalysis over the last 10 years.
In this interview, Mark Arnold (Covance, NJ, USA) discusses the scope of the draft ICH M10 guidance as well as explaining the difference between full, partial and cross validation and how to choose which validation to use and when.
The 10th Japan Bioanalysis Forum Symposium took place between 12–14 February 2019 (Yokohoma, Japan). The 3-day symposium aimed to foster collaboration and featured a broad range of programs. This conference report summarizes the major topics covered.
In this interview, Eric Woolf (Merck; PA, USA) provides an overview of the draft ICH M10 guidance for bioanalytical method validation, indicating why there is a need for new guidance and discussing possible disadvantages of such a collective consensus guidance.
In this editorial from Bioanalysis, a collection of experts from CROs across the globe provide a CRO perspective on the potential impact of the ICH M10 guidance.
In this interview, John Kadavil (FDA, MD, USA) discusses what he expected from the draft ICH M10 guidance and speculates on the potential challenges that may be encountered as laboratories begin to implement the new guidance.