Browsing: validation

Biomarkers Biomarkers Spotlight

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.

Research Spotlight research

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.

Journal Articles regulation guidelines

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.

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