Mike Brown (Q-Squared Solutions; GA, USA), discusses the different tests required when looking at a potential therapeutic and what aspects of biology need to be considered. He also explores how important early engagement with the FDA and clinical trial partners are.
Browsing: method development
As part of our Spotlight, we present this interview with Cory Muraco (Merck KGaA, Darmstadt, Germany) who discusses his interest in chromatography, the technologies he uses and his top three tips for chromatographic method development.
In this perspective piece, a general discussion on the importance of these matrix effects is provided as well as how to properly address them in the method-development and validation stages of regulated bioanalysis.
This article discusses membrane-based distillation ion chromatography as a new bioanalytical method. Find out more in this article from Bioanalysis.
Parallelism experiments to evaluate matrix effects, selectivity and sensitivity in ligand-binding assay method development: pros and cons
This review compares and discusses all available approaches that can be used to assess key assay parameters for pharmacokinetic and biomarker ligand-binding assays. Find out more in this article from Bioanalysis.
Researchers have developed a new technique that could potentially detect single cell melanomas with a greater accuracy and efficiency than previous methods.
In this special report from Bioanalysis , the authors report on the importance of physiologically relevant quantitative bioanalytical assays. They share experiences from project support (internal and at CROs) that suggests the need to be ever vigilant translating the needs of bioanalysis with those of project teams.
A simple, effective approach for rapid development of high-throughput and reliable LC–MS/MS bioanalytical assays
In this article, the authors describe a simple, effective approach to achieve accelerated method development of high-throughput and reliable LC–MS/MS assays for regulated bioanalysis.
HRMS using a Q-Exactive series mass spectrometer for regulated quantitative bioanalysis: how, when, and why to implement
In this article, the authors describe how, when, and why HRMS (specifically Q-Exactive series mass spectrometers) should be considered for implementation in regulated quantitative bioanalysis assays.
Researchers have developed a new method to rapidly detect a single virus in a urine sample, and suggest that it could be adapted to detect Ebola, HIV and Zika viruses.