National Academies of Sciences%2c Engineering%2c and Medicine

Genome-Based Therapeutics: Targeted Drug Discovery and Development: Workshop Summary

• 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 ...
National Academies of Sciences%2c Engineering%2c and Medicine

Building a National Framework for the Establishment of Regulatory Science for Drug ...

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 ...
PharmTech

Part VII GMPs for Small Molecule Drugs in Early Development Workshop Summary

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 ...