Biomarker ligand-binding assays need to be validated for use on clinical studies in the drug development process. There is not one single guidance to cover all types of biomarker assays and their intended uses. Therefore, it is up to the scientist to piece together a validation strategy based on published papers and other sources. Shown here is a summary of what to take into consideration during a validation and how to apply it for use in the drug development process.
Keywords:
- biomarker
- biomarker validation
- fit-for-purpose
- intended use