<a href="https://www.bioagilytix.com/blog/category/biomarkers/">Biomarkers</a>
Is ISR Needed For Biomarker Assays?
Incurred sample reanalysis (ISR) is a well-established measure for the reproducibility of pharmacokinetic (PK) assays and commonly conducted in regulated studies. ISR was established in…
<a href="https://www.bioagilytix.com/blog/category/biomarkers/">Biomarkers</a>
Difference Between Biobetters and Biosimilars
According to research compiled by Reports and Data, in 2018 the global biologics market was valued at over $250 million, but is projected to reach…
<a href="https://www.bioagilytix.com/blog/category/biomarkers/">Biomarkers</a>
C-Path “Points to Consider Document” Clarifies Bioanalytical Assay Validation in Support of Clinical Biomarker Qualification
A contributing author to the Critical Path Institute (C-Path)’s “Points to Consider Document,” Dr. Afshin Safavi summarizes considerations outlined in the paper designed to establish…
<a href="https://www.bioagilytix.com/blog/category/bioagilytix-insight/">BioAgilytix Insight</a>
510K Approved Assays vs. RUO Assays: Which Best Support Clinical Trial Biomarker Studies?
The answer to the question is “it depends”. Commonly a combination of 510K approved kits (in Europe known as assays that need to follow IVD-directive…