Find out more about the validation of biomarkers in this interview with Hanna Ritzén, Managing Director Research and Development at Mercodia AB (Uppsala, Sweden).
To kick-start this special focus, we wanted to hear your thoughts on the topic – complete our short survey on the validation of biomarkers and be the first to receive our informative infographic collated from the survey results.
In this Spotlight, we will be revisiting some of the key issues raised in a previous Spotlight: Biomarkers (and biosensors), as well as investigating advancements in the field and the development of techniques. We will hear from experts in the field about the key challenges they face, how they overcome them and how their research is helping to advance the development of human healthcare.
Commercial assays for biomarker detection frequently utilize different reagents which each manufacturer considers proprietary. Subsequently, results may not match from vendor to vendor. Read how one group performed their own internal validation studies to address these concerns and effectively measure IL-6 and sIL-6R in patients following CAR T cell therapy.
Single molecule counting (SMC™) technology enables precise measurement of molecules at levels previously undetectable, down to the femtogram/mL levels, allowing researchers to identify new biomarkers or assist in therapeutic development with an improved view of efficacy, safety and time course studies. Find out more in this video webinar from Millipore Sigma (MA, USA).
“Insulin assays have been used for decades, and although they were validated once upon a time, industry guidelines have since been updated, improved and changed. How do these old methods stand against modern needs and requirements?
In these two parts, Hanna Ritzén, Managing Director of Research and Development at Mercodia (Uppsala, Sweden), gives an introduction to life cycle management and how it can be implemented to improve and keep consistent measurement quality.
Validated UHPLC–MS/MS method for quantification of doxycycline in abdominal aortic aneurysm patients
Read more about this development and validation of a selective, specific, simple and rapid UHPLC–MS/MS method for doxycycline, in our featured article from Bioanalysis.
Read time: 4:30 mins
In this column, Afshin Safavi differentiates between ‘assay qualification’ and ‘assay validation’ explaining current industry guidance, the translation of this guidance into the exploratory biomarker world, and how BioAgilytix (NC, USA) approaches these challenges.
Implementing a tiered approach to bioanalytical method validation for large-molecule ligand-binding assay methods in pharmacokinetic assessments
Bioanalytical methods must enable the delivery of data that meet sound, scientifically justified, fit-for-purpose criteria. This perspective piece highlights three tiers of method validation – regulatory, scientific and research validations. The criteria for selecting the appropriate application of each of these PK method validation workflows are discussed.