Reverse Translation in PBPK and QSP: Going Backwards in Order to Go Forward With Confidence-Reference-Cited by-同舟云学术

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

Published:2017-11-09 Issue:2 Volume:103 Page:224-232
ISSN:0009-9236
Container-title:Clinical Pharmacology & Therapeutics
language:en
Short-container-title:Clin. Pharmacol. Ther.

Author:

Rostami-Hodjegan Amin¹²

Affiliation:

1. Centre for Applied Pharmacokinetics Research (CAPKR); University of Manchester; Manchester UK

2. Certara, Blades Enterprise Centre; Sheffield UK

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

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3. European Medicines Agency EMA/CHMP/458101/2016 - Guideline on the qualification and reporting of physiologically based pharmacokinetic (PBPK) modeling and Simulation Draft http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2016/07/WC500211315.pdf > 2017

4. U.S. Food and Drug Administration Physiologically Based Pharmacokinetic Analyses - Format and Content. Guidance for Industry https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM531207.pdf 2017

5. Combining the ‘bottom up’ and ‘top down’ approaches in pharmacokinetic modeling: fitting PBPK models to observed clinical data;Tsamandouras;Br. J. Clin. Pharmacol.,2015

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