Application of Physiologically Based Pharmacokinetic (PBPK) Modeling to Support Dose Selection: Report of an FDA Public Workshop on PBPK-Reference-Cited by-同舟云学术

Application of Physiologically Based Pharmacokinetic (PBPK) Modeling to Support Dose Selection: Report of an FDA Public Workshop on PBPK

Published:2015-04 Issue:4 Volume:4 Page:226-230
ISSN:2163-8306
Container-title:CPT: Pharmacometrics & Systems Pharmacology
language:en
Short-container-title:CPT Pharmacometrics Syst. Pharmacol.

Author:

Wagner C¹,Zhao P¹,Pan Y²,Hsu V¹,Grillo J¹,Huang SM¹,Sinha V¹

Affiliation:

1. Office of Clinical Pharmacology, Office of Translational Sciences, US Food and Drug Administration, Silver Spring Maryland USA

2. Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver SpringMaryland USA

Publisher

Wiley

Subject

Pharmacology (medical),Modeling and Simulation

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/psp4.33

Reference7 articles.

1. Federal Register: FDA Public Workshop “Application of Physiologically‐Based Pharmacokinetic Modeling to Support Dose Selection.” (2014).

2. 2014 FDA Public Workshop: Application of Physiologically‐Based Pharmacokinetic Modeling to Support Dose Selection. (2014). Accessed on 27 October 2014.

3. Predicting the Effect of Cytochrome P450 Inhibitors on Substrate Drugs: Analysis of Physiologically Based Pharmacokinetic Modeling Submissions to the US Food and Drug Administration

4. PBPK Model Describes the Effects of Comedication and Genetic Polymorphism on Systemic Exposure of Drugs That Undergo Multiple Clearance Pathways

5. Ibrutinib Clinical Pharmacology and Biopharmaceutics Review. (2013). Accessed on 2 February 2014.

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