PDUFA VI: It Is Time to Unleash the Full Potential of Model‐Informed Drug Development
Author:
Affiliation:
1. Quantitative Pharmacology and PharmacometricsPharmacokinetics Pharmacodynamics and Drug MetabolismMerck & Co., Inc. Kenilworth New Jersey USA
Funder
Merck
Publisher
Wiley
Subject
Pharmacology (medical),Modeling and Simulation
Link
https://onlinelibrary.wiley.com/doi/pdf/10.1002/psp4.12365
Reference10 articles.
1. FDA guidance for industry: providing clinical evidence of effectiveness for human drug and biologic products. (May 1998)
2. US FDA voice by Commissioner Dr. Scott Gottlieb article on “How FDA Plans to Help Consumer Capitalize on Advances in Science.”
3. Good Practices in Model-Informed Drug Discovery and Development: Practice, Application, and Documentation
4. Getting Innovative Therapies Faster to Patients at the Right Dose: Impact of Quantitative Pharmacology Towards First Registration and Expanding Therapeutic Use
5. Prevision Policy article.A new model for drug development: FDA sees chance to use modeling to shortcut early development: workshop is “first‐step” on “long journey.” (February 8 2018)
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