Technology Digest: single-analyte biomarker assays for pharmacodynamic or safety assessment during biotherapeutic development
When used to make decisions concerning regulatory submissions and drug development, it is essential that biomarker assays deliver high performance and reliability. As development progresses through preclinical and clinical phases, the value of high-quality, well-characterized single-analyte assays with suitably high sensitivity, reproducibility and broad dynamic range becomes essential to the utility of these assays as surrogate endpoints, efficacy markers or safety biomarkers for validation of regulated studies.
In this Tech Digest, we review multiplex and singleplex assays for biotherapeutic development and provide an overview of the Gyrolab® microfluidic immunoassay platform for biomarkers.
This eBook includes:
- TECHNOLOGY DIGEST: Single-analyte biomarker assays for pharmacodynamic or safety assessment during biotherapeutic development
- WHITE PAPER: Analytical method validation for biomarkers as a drug development tool: points to consider
- COMMENTARY: A guided approach to preclinical bioanalysis of proteins using immunoassays for pharmacokinetic and pharmacodynamic assessments
- WHITE PAPER: Biomarker context-of-use: how organizational design can impact the implementation of the appropriate biomarker assay strategy