Model‐Informed Drug Development: Current US Regulatory Practice and Future Considerations-Reference-Cited by-同舟云学术

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Model‐Informed Drug Development: Current US Regulatory Practice and Future Considerations

Published:2019-03 Issue:4 Volume:105 Page:899-911
ISSN:0009-9236
Container-title:Clinical Pharmacology & Therapeutics
language:en
Short-container-title:Clin. Pharmacol. Ther.

Author:

Wang Yaning¹,Zhu Hao¹,Madabushi Rajanikanth¹,Liu Qi¹,Huang Shiew‐Mei¹,Zineh Issam¹

Affiliation:

1. Office of Clinical PharmacologyOffice of Translational SciencesUS Food and Drug Administration Silver Spring Maryland USA

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/cpt.1363

Reference85 articles.

1. Concepts and Challenges in Quantitative Pharmacology and Model-Based Drug Development

2. Opportunities for integration of pharmacokinetics, pharmacodynamics, and toxicokinetics in rational drug development

3. Learning versus confirming in clinical drug development*

4. Model-based Drug Development

5. Model-Based Drug Development: A Rational Approach to Efficiently Accelerate Drug Development

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4. Model-informed drug development in pediatric, pregnancy and geriatric drug development: States of the art and future;Advanced Drug Delivery Reviews;2024-08

5. Evolution of Drug Development and Regulatory Affairs: The Demonstrated Power of Artificial Intelligence;Clinical Therapeutics;2024-08

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