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

Regulatory Science ◽

Physiologically Based ◽

The U.S

Utilization of Physiologically Based Pharmacokinetic Modeling in Clinical Pharmacology and Therapeutics: an Overview

Current Pharmacology Reports ◽

10.1007/s40495-020-00212-x ◽

2020 ◽

Vol 6 (3) ◽

pp. 71-84 ◽

Cited By ~ 1

Author(s):

Courtney Perry ◽

Grace Davis ◽

Todd M. Conner ◽

Tao Zhang

Keyword(s):

Clinical Pharmacology ◽

Development of best practices in physiologically based pharmacokinetic modeling to support clinical pharmacology regulatory decision‐making—A workshop summary

CPT Pharmacometrics & Systems Pharmacology ◽

10.1002/psp4.12706 ◽

2021 ◽

Author(s):

Daphney Jean ◽

Kunal Naik ◽

Lauren Milligan ◽

Stephen Hall ◽

Shiew Mei Huang ◽

...

Keyword(s):

Decision Making ◽

Clinical Pharmacology ◽

Best Practices ◽

Regulatory Decision ◽

Physiologically Based ◽

Workshop Summary

Best Practice in the Use of Physiologically Based Pharmacokinetic Modeling and Simulation to Address Clinical Pharmacology Regulatory Questions

Clinical Pharmacology & Therapeutics ◽

10.1038/clpt.2012.68 ◽

2012 ◽

Vol 92 (1) ◽

pp. 17-20 ◽

Cited By ~ 127

Author(s):

P Zhao ◽

M Rowland ◽

S-M Huang

Keyword(s):

Clinical Pharmacology ◽

Modeling And Simulation ◽

Best Practice ◽

Pharmacokinetic Modeling And Simulation

Physiologically Based ◽

Physiologically Based Pharmacokinetic Modeling: From Regulatory Science to Regulatory Policy

Clinical Pharmacology & Therapeutics ◽

10.1038/clpt.2014.46 ◽

2014 ◽

Vol 95 (5) ◽

pp. 478-480 ◽

Cited By ~ 35

Author(s):

V Sinha ◽

P Zhao ◽

S M Huang ◽

I Zineh

Keyword(s):

Regulatory Policy ◽

Regulatory Science ◽

Physiologically based pharmacokinetic modeling ( PBPK 's) prediction potential in clinical pharmacology decision making during pregnancy

International Journal of Gynecology & Obstetrics ◽

10.1002/ijgo.13150 ◽

2020 ◽

Vol 150 (3) ◽

pp. 414-416 ◽

Cited By ~ 1

Author(s):

Ahizechukwu C. Eke ◽

Rahel D. Gebreyohannes

Keyword(s):

Decision Making ◽

Clinical Pharmacology ◽

Physiologically-based pharmacokinetic modeling of different size polyethylene glycol-coated gold nanoparticles in mice

10.1615/ihtc16.nmt.023362 ◽

2018 ◽

Author(s):

Linjing Deng ◽

Jinping Zhao ◽

Yufeng Miao ◽

Xu Hu ◽

Qihong Deng

Keyword(s):

Gold Nanoparticles ◽

Polyethylene Glycol ◽

Physiologically-Based Pharmacokinetic Modeling to Predict Changes in Drug Exposure during Pregnancy Using the Simcyp Simulator

10.26226/morressier.57d6b2b7d462b8028d88e945 ◽

2016 ◽

Author(s):

Suvarchala Kiranmai Avvari

Keyword(s):

Drug Exposure ◽

Physiologically Based ◽

Exposure During Pregnancy

Physiologically‐Based Pharmacokinetic Modeling of Atorvastatin Incorporating Delayed Gastric Emptying and Acid‐to‐Lactone Conversion

CPT Pharmacometrics & Systems Pharmacology ◽

10.1002/psp4.12447 ◽

2019 ◽

Vol 8 (9) ◽

pp. 664-675 ◽

Cited By ~ 5

Author(s):

Bridget L. Morse ◽

Jeffrey J. Alberts ◽

Maria M. Posada ◽

Jessica Rehmel ◽

Anil Kolur ◽

...

Keyword(s):

Gastric Emptying ◽

Delayed Gastric Emptying ◽

Preliminary physiologically based pharmacokinetic modeling of renally cleared drugs in Chinese pregnant women

Biopharmaceutics & Drug Disposition ◽

10.1002/bdd.2243 ◽

2020 ◽

Vol 41 (6) ◽

pp. 248-267 ◽

Cited By ~ 1

Author(s):

Ling Song ◽

Zhiheng Yu ◽

Yifan Xu ◽

Xiaobei Li ◽

Xuanlin Liu ◽

...

Keyword(s):

Pregnant Women ◽

Prediction of fluoxetine and norfluoxetine pharmacokinetic profiles using physiologically based pharmacokinetic modeling

The Journal of Clinical Pharmacology ◽

10.1002/jcph.1927 ◽

2021 ◽

Author(s):

Hyeon‐Cheol Jeong ◽

Yoon‐Jee Chae ◽

Sooyeun Lee ◽

Wonku Kang ◽

Hwi‐yeol Yun ◽

...

Keyword(s):

Pharmacokinetic Profiles ◽