Overview:
Bioassay development and validation is very critical in pre-clinical drug discovery, clinical biomarker and translational research, diagnostic product (including companion diagnostic) development. In this presentation, overview if given for the terminologies, the scientific principles, and the regulatory guidelines that are related to assay validation.
Then each of the assay performance characteristics (specificity, sensitivity, accuracy, precision, linearity, stability, reportable range, reference range) will be explained in terms of experimental design and statistical analysis.