Usage of In Vitro Metabolism Data for Drug‐Drug Interaction in Physiologically Based Pharmacokinetic Analysis Submissions to the US Food and Drug Administration-Reference-Cited by-同舟云学术

Usage of In Vitro Metabolism Data for Drug‐Drug Interaction in Physiologically Based Pharmacokinetic Analysis Submissions to the US Food and Drug Administration

Published:2021-02-09 Issue:6 Volume:61 Page:782-788
ISSN:0091-2700
Container-title:The Journal of Clinical Pharmacology
language:en
Short-container-title:The Journal of Clinical Pharmacology

Author:

Lee Jieon¹,Yang Yuching¹,Zhang Xinyuan¹,Fan Jianghong¹,Grimstein Manuela¹,Zhu Hao¹,Wang Yaning¹

Affiliation:

1. Office of Clinical Pharmacology Office of Translational Sciences Center for Drug Evaluation and Research US Food and Drug Administration Silver Spring Maryland USA

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/jcph.1819

Reference25 articles.

1. Physiologically Based Pharmacokinetic Model Qualification and Reporting Procedures for Regulatory Submissions: A Consortium Perspective

2. Advancing Predictions of Tissue and Intracellular Drug Concentrations Using In Vitro , Imaging and Physiologically Based Pharmacokinetic Modeling Approaches

3. Physiologically Based Pharmacokinetic Modeling in Regulatory Science: An Update From the U.S. Food and Drug Administration’s Office of Clinical Pharmacology

4. Application of PBPK modeling and simulation for regulatory decision making and its impact on US Prescribing Information: an update on the 2018‐2019 submissions to the US FDA's Office of Clinical Pharmacology;Zhang X;J Clin Pharmacol,2020

5. PBPK modeling and simulation in drug research and development

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