Extended Model-Informed Drug Development: Beyond Clinical Trials and Regulatory Approval

Clin Pharmacol Ther. 2024 Sep;116(3):518-521. doi: 10.1002/cpt.3357. Epub 2024 Jul 15.

Authors

Mohamed A Kamal¹, Samit Ganguly¹, Ananth Kadambi², Patrick F Smith²

Affiliations

¹ Regeneron Pharmaceuticals, Tarrytown, New York, USA.
² Certara, Princeton, New Jersey, USA.

PMID: 39010652
DOI: 10.1002/cpt.3357

No abstract available

MeSH terms

Clinical Trials as Topic* / methods
Drug Approval*
Drug Development* / legislation & jurisprudence
Drug Development* / methods
Humans
Models, Biological
United States
United States Food and Drug Administration