Popis: |
The continued development of biomarkers and true surrogate markers throughout the drug development value chain in the service of drug registration will remain an important activity to increase efficiency in the drug development process. Academic, pharmaceutical, and regulatory agency partnerships to develop biomarkers collaboratively. This article focuses on biomarker development in preclinical models, in clinical trials, and in partnership with regulatory agencies. Keywords: biomarkers; surrogate markers; drug development; preclinical models; clinical trials |