Quantitative Systems Pharmacology: A Regulatory Perspective on Translation
Issam Zineh · CPT Pharmacometrics & Systems Pharmacology · 2019
Interest in QSP as an approach to mechanistically inform drug development has exploded in recent years.Additionally, both drug development and regulatory scientists have increasingly expressed interest in the potential for QSP to guide regulatory decisions.The extent to which QSP can routinely do either is an open question, and there have been examples of QSP facilitating key decisions and transitions in drug discovery and development.