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Category: Biomarkers

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…

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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…

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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…

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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…

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