Physiologically Based Pharmacokinetics as a Component of Model‐Informed Drug Development: Where We Were, Where We Are, and Where We Are Heading-Reference-Cited by-同舟云学术

Physiologically Based Pharmacokinetics as a Component of Model‐Informed Drug Development: Where We Were, Where We Are, and Where We Are Heading

Published:2020-11 Issue:S1 Volume:60 Page:
ISSN:0091-2700
Container-title:The Journal of Clinical Pharmacology
language:en
Short-container-title:The Journal of Clinical Pharmacology

Author:

Rostami‐Hodjegan Amin¹²,Toon Stephen²

Affiliation:

1. Centre for Applied Pharmacokinetic Research (CAPKR) The University of Manchester Manchester UK

2. Certara UK Limited Simcyp Division Sheffield UK

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/jcph.1654

Reference19 articles.

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

3. Regulatory Considerations for Building an In Silico Clinical Pharmacology Backbone by 2030

4. Reverse Translation in PBPK and QSP: Going Backwards in Order to Go Forward With Confidence

5. FDA. PDUFA reauthorization performance goals and procedures fiscal years 2018 through 2022.https://www.fda.gov/media/99140/download. Published October 2016. Accessed May 22 2020.

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