Physiologically based pharmacokinetic modeling in regulatory decision-making at the European Medicines Agency

Clinical Pharmacology & Therapeutics ◽

10.1002/cpt.539 ◽

2016 ◽

Vol 102 (1) ◽

pp. 98-105 ◽

Author(s):

E Luzon ◽

K Blake ◽

S Cole ◽

A Nordmark ◽

C Versantvoort ◽

...

Keyword(s):

Decision Making ◽

Pharmacokinetic Modeling ◽

European Medicines Agency ◽

Physiologically Based Pharmacokinetic Modeling ◽

Regulatory Decision ◽

Physiologically Based Pharmacokinetic ◽

Physiologically Based

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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 ◽

Pharmacokinetic Modeling ◽

Physiologically Based Pharmacokinetic Modeling ◽

Regulatory Decision ◽

Physiologically Based Pharmacokinetic ◽

Physiologically Based ◽

Workshop Summary

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Challenges Associated With Applying Physiologically Based Pharmacokinetic Modeling for Public Health Decision-Making

Toxicological Sciences ◽

10.1093/toxsci/kfy010 ◽

2018 ◽

Vol 162 (2) ◽

pp. 341-348 ◽

Author(s):

Yu-Mei Tan ◽

Rachel R Worley ◽

Jeremy A Leonard ◽

Jeffrey W Fisher

Keyword(s):

Public Health ◽

Decision Making ◽

Pharmacokinetic Modeling ◽

Physiologically Based Pharmacokinetic Modeling ◽

Public Health Decision ◽

Health Decision Making ◽

Physiologically Based Pharmacokinetic ◽

Physiologically Based ◽

Health Decision

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Corrigendum to “Challenges Associated With Applying Physiologically Based Pharmacokinetic Modeling for Public Health Decision-Making”

Toxicological Sciences ◽

10.1093/toxsci/kfy034 ◽

2018 ◽

Vol 162 (2) ◽

pp. 724-724 ◽

Author(s):

Yu-Mei Tan ◽

Rachel Worley ◽

Jeremy A Leonard ◽

Jeffrey Fisher

Keyword(s):

Public Health ◽

Decision Making ◽

Pharmacokinetic Modeling ◽

Physiologically Based Pharmacokinetic Modeling ◽

Public Health Decision ◽

Health Decision Making ◽

Physiologically Based Pharmacokinetic ◽

Physiologically Based ◽

Health Decision

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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 ◽

Author(s):

Ahizechukwu C. Eke ◽

Rahel D. Gebreyohannes

Keyword(s):

Decision Making ◽

Clinical Pharmacology ◽

Pharmacokinetic Modeling ◽

Physiologically Based Pharmacokinetic Modeling ◽

Physiologically Based Pharmacokinetic ◽

Physiologically Based

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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 ◽

Pharmacokinetic Modeling ◽

Physiologically Based Pharmacokinetic Modeling ◽

Physiologically Based Pharmacokinetic ◽

Physiologically Based

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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 ◽

Pharmacokinetic Modeling ◽

Physiologically Based Pharmacokinetic Modeling ◽

Physiologically Based Pharmacokinetic ◽

Physiologically Based ◽

Exposure During Pregnancy

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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 ◽

Author(s):

Bridget L. Morse ◽

Jeffrey J. Alberts ◽

Maria M. Posada ◽

Jessica Rehmel ◽

Anil Kolur ◽

...

Keyword(s):

Gastric Emptying ◽

Delayed Gastric Emptying ◽

Pharmacokinetic Modeling ◽

Physiologically Based Pharmacokinetic Modeling ◽

Physiologically Based Pharmacokinetic ◽

Physiologically Based

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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 ◽

Author(s):

Ling Song ◽

Zhiheng Yu ◽

Yifan Xu ◽

Xiaobei Li ◽

Xuanlin Liu ◽

...

Keyword(s):

Pregnant Women ◽

Pharmacokinetic Modeling ◽

Physiologically Based Pharmacokinetic Modeling ◽

Physiologically Based Pharmacokinetic ◽

Physiologically Based

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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 Modeling ◽

Physiologically Based Pharmacokinetic Modeling ◽

Physiologically Based Pharmacokinetic ◽

Pharmacokinetic Profiles ◽

Physiologically Based

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Physiologically Based Pharmacokinetic Modeling Approach to Predict Drug‐Drug Interactions With Ethionamide Involving Impact of Genetic Polymorphism on FMO3

The Journal of Clinical Pharmacology ◽

10.1002/jcph.1378 ◽

2019 ◽

Vol 59 (6) ◽

pp. 880-889 ◽

Author(s):

Phuong Thi Thu Nguyen ◽

Md Masud Parvez ◽

Min Jung Kim ◽

Sung Eun Yoo ◽

Sangzin Ahn ◽

...

Keyword(s):

Genetic Polymorphism ◽

Drug Interactions ◽

Pharmacokinetic Modeling ◽

Physiologically Based Pharmacokinetic Modeling ◽

Modeling Approach ◽

Physiologically Based Pharmacokinetic ◽

Physiologically Based

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