IntegratingIn Vitro, Modeling, andIn VivoApproaches to Investigate Warfarin Bioequivalence-Reference-Cited by-同舟云学术

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IntegratingIn Vitro, Modeling, andIn VivoApproaches to Investigate Warfarin Bioequivalence

Published:2017-07-13 Issue:8 Volume:6 Page:523-531
ISSN:2163-8306
Container-title:CPT: Pharmacometrics & Systems Pharmacology
language:en
Short-container-title:CPT Pharmacometrics Syst. Pharmacol.

Author:

Zhang X¹,Wen H¹,Fan J¹,Vince B²,Li T³,Gao W³,Kinjo M¹,Brown J⁴,Sun W⁴,Jiang W¹,Lionberger R¹

Affiliation:

1. Office of Generic Drugs, US Food and Drug Administration; Silver Spring Maryland USA

2. Vince and Associates Clinical Research Inc; Overland Park Kansas USA

3. Department of Industrial and Physical Pharmacy; Purdue University; West Lafayette Indiana USA

4. Office of Translational Sciences, US Food and Drug Administration; Silver Spring Maryland USA

Funder

U.S. Food and Drug Administration

Publisher

Wiley

Subject

Pharmacology (medical),Modelling and Simulation

Reference19 articles.

1. Recent advances in development and application of physiologically-based pharmacokinetic (PBPK) models: a transition from academic curiosity to regulatory acceptance;Jamei;Curr. Pharmacol. Rep.,2016

2. PBPK as a tool in regulatory review;Huang;Biopharm. Drug Dispos.,2012

3. Applications of physiologically based pharmacokinetic (PBPK) modeling and simulation during regulatory review;Zhao;Clin. Pharmacol. Ther.,2011

4. The role of predictive biopharmaceutical modeling and simulation in drug development and regulatory evaluation;Jiang;Int. J. Pharm.,2011

5. Modeling and simulation of biopharmaceutical performance;Zhang;Clin. Pharmacol. Ther.,2014

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1. Establishing Virtual Bioequivalence and Clinically Relevant Specifications for Omeprazole Enteric-Coated Capsules by Incorporating Dissolution Data in PBPK Modeling;The AAPS Journal;2024-07-12

2. A physiologically‐based pharmacokinetic/pharmacodynamic modeling approach for drug–drug‐gene interaction evaluation of S‐warfarin with fluconazole;CPT: Pharmacometrics & Systems Pharmacology;2024-03-15

3. Predicting bioequivalence and developing dissolution bioequivalence safe space in vitro for warfarin using a Physiologically-Based pharmacokinetic absorption model;European Journal of Pharmaceutics and Biopharmaceutics;2023-10

4. VIRTUAL BIOEQUIVALENCE IN PHARMACEUTICALS: CURRENT STATUS AND FUTURE PROSPECTS;International Journal of Applied Pharmaceutics;2023-09-07

5. Physiologically Based Pharmacokinetic Model Development and Verification for Bioequivalence Testing of Bempedoic Acid Oral Suspension and Reference Tablet Formulation;Pharmaceutics;2023-05-12

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