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…
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…
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…
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…