Tagged: Surrogate Markers
In orphan diseases and precision medicine, developing a biomarker plan during translation into early clinical development moves treatment to market faster, and still meets the FDA’s expectations.
June 15th, 2023 | Surrogate MarkersInterest is increasing rapidly in using surrogate markers as primary measures of the effectiveness of investigational drugs in definitive drug trials.
January 10th, 2023 | Surrogate Markers
The primary difference between a biomarker and a surrogate marker is that a biomarker is a “candidate” surrogate marker. In contrast, a surrogate marker is a test used and taken to measure the effects of a specific treatment. While the current law and regulations permit the FDA to base the approval of a drug product […]