• The development of drugs and companion diagnostics requires the collection of rigorous and reliable chemical, pharmaceutical, and biological data. • Candidate gene association studies can identify ...
The concept of regulatory science is not a new one. The FDA Science Board’s 2007 Science and Mission at Risk report (FDA Science Board, 2007) describes regulatory science as a science-based ...
This executive summary focuses on dose-flexible manufacturing strategies and their role in drug development. Dose flexibility is increasingly important for early clinical studies, particularly in ...