404

PAGE NOT FOUND

Biomarker Assay Validation

By Dr. Lauren Stevenson | October 5, 2021 | Comments Off on Biomarker Assay Validation

Biomarker Assay Validation: Scientific Considerations As defined by the BeST glossary, a biomarker is a characteristic that is measured as an indicator of normal biological processes, pathogenic processes, or biological responses to an exposure or intervention, including therapeutic interventions. Bioanalytical method validation of biomarker assays ensures that the method reliably measures the biomarker of interest…

Implementing Best Practices for the Characterization of Critical Reagents

By EGregos@immunologixlabs.com | October 5, 2021 | Comments Off on Implementing Best Practices for the Characterization of Critical Reagents

Years of bioanalytical assay development have established that the quality, consistency, and specificity of assay results depend largely on the critical reagents selected for development.  Today, there is no guidance for the proper characterization of, testing requirements for, or the allowable batch variability in reagents used to support clinical studies.  Because there is no regulatory…

Cell Based Assays in Drug Development: Comprehensive Overview

By Dr. Corinna Fiorotti | September 24, 2021 | Comments Off on Cell Based Assays in Drug Development: Comprehensive Overview

Cell-based assays and analysis play a vital role in every stage of the drug development process from early discovery, pre-clinical, clinical and post market commitment phases.  Cell-based assays are an analytical measurement defined by a set of reagents that produce a detectable signal for quantifying a biological process. In this blog, we are going to cover…