Scientific and regulatory evaluation of empirical pharmacometric models: An application of the risk informed credibility assessment framework
Author:
Affiliation:
1. The Norwegian Medicines Agency Oslo Norway
2. EMA Modelling and Simulation Working Party Amsterdam The Netherlands
3. Federal Agency for Medicines and Health Products (FAMHP) Brussels Belgium
Publisher
Wiley
Subject
Pharmacology (medical),Modeling and Simulation
Link
https://onlinelibrary.wiley.com/doi/pdf/10.1002/psp4.12708
Reference20 articles.
1. Learning versus confirming in clinical drug development*
2. OODA loop.Wikipedia.https://en.wikipedia.org/wiki/OODA_loopAccessed January 24 2021.
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4. Model‐Informed Drug Development: Current US Regulatory Practice and Future Considerations
5. The Role of Modeling and Simulation in Development and Registration of Medicinal Products: Output From the EFPIA/EMA Modeling and Simulation Workshop
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