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 Development: Workshop Summary

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

GMPs for Small-Molecule Drugs in Early Development: Workshop Summary-Part VI

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 ...
PharmTech

Flexible-Dose Development Strategies for Today's Clinical Landscape - Executive Summary

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 ...
University of Sheffield

Evidencing Development Summary

The Evidencing Development summary is the principal means by which your progress on the Doctoral Development Programme (DDP) is monitored. The purpose of the summary is to provide a record of your ...