Search Results for: ASSAY VALIDATION Biomarker Assay Validations

Articles

- ASSAY VALIDATIONBiomarker Assay Validations – A Time for Change?

John L. Allinson, FIBMS, believes despite the increased use of biomarkers, it appears that many researchers are still continuing to use the FDA guidance document for validation even though it only critically addresses the validation of assays to support PK evaluation, and also has a limited scope described within the document in terms of studies where it should be used.