Pharmacodynamic (Response) Biomarker: A response biomarker that indicates biologic activity of a medical product or environmental agent without necessarily drawing conclusions about efficacy or disease outcome or necessarily linking this activity to an established mechanism of action.
Used for proof-of-concept, assisting in dose selection, measuring a response or potential harm to medical products. May be secondary endpoints in clinical trials and may be described in labeling.
BEST (Biomarkers, EndpointS, and other Tools) Resource. FDA-NIH Biomarker Working Group. Last Updated: November 29, 2021. https://www.ncbi.nlm.nih.gov/books/NBK326791/pdf/Bookshelf_NBK326791.pdf
Recent Comments