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 ...
• 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 authors explore and define common industry approaches and practices when applying GMPs in early development. The International Consortium on Innovation and Quality in Pharmaceutical Development ...
It is striking how development priorities have aligned over the past five years. Countries of all income levels are prioritizing their transition to digital and ‘green’ economies, in parallel. This ...
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 ...
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