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