Regulatory Experience With Physiologically Based Pharmacokinetic Modeling for Pediatric Drug Trials

R Leong; M L T Vieira; P Zhao; Y Mulugeta; C S Lee; S-M Huang; G J Burckart

doi:10.1038/clpt.2012.19

Regulatory Experience With Physiologically Based Pharmacokinetic Modeling for Pediatric Drug Trials

Clinical Pharmacology & Therapeutics ◽

10.1038/clpt.2012.19 ◽

2012 ◽

Vol 91 (5) ◽

pp. 926-931 ◽

Cited By ~ 118

Author(s):

R Leong ◽

M L T Vieira ◽

P Zhao ◽

Y Mulugeta ◽

C S Lee ◽

...

Keyword(s):

Pharmacokinetic Modeling ◽

Drug Trials ◽

Physiologically Based Pharmacokinetic Modeling ◽

Pediatric Drug ◽

Physiologically Based Pharmacokinetic ◽

Physiologically Based

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State-of-the-Art Review on Physiologically Based Pharmacokinetic Modeling in Pediatric Drug Development

Clinical Pharmacokinetics ◽

10.1007/s40262-018-0677-y ◽

2018 ◽

Vol 58 (1) ◽

pp. 1-13 ◽

Cited By ~ 19

Author(s):

Venkata Yellepeddi ◽

Joseph Rower ◽

Xiaoxi Liu ◽

Shaun Kumar ◽

Jahidur Rashid ◽

...

Keyword(s):

Drug Development ◽

State Of The Art ◽

Pharmacokinetic Modeling ◽

Physiologically Based Pharmacokinetic Modeling ◽

Pediatric Drug ◽

Pediatric Drug Development ◽

Physiologically Based Pharmacokinetic ◽

Physiologically Based

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A best practice framework for applying physiologically‐based pharmacokinetic modeling to pediatric drug development

CPT Pharmacometrics & Systems Pharmacology ◽

10.1002/psp4.12678 ◽

2021 ◽

Author(s):

Trevor N. Johnson ◽

Ben G. Small ◽

Eva Gil Berglund ◽

Karen Rowland Yeo

Keyword(s):

Drug Development ◽

Best Practice ◽

Pharmacokinetic Modeling ◽

Physiologically Based Pharmacokinetic Modeling ◽

Pediatric Drug ◽

Pediatric Drug Development ◽

Physiologically Based Pharmacokinetic ◽

Physiologically Based ◽

Practice Framework

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Physiologically Based Pharmacokinetic Modeling and Simulation in Pediatric Drug Development

CPT Pharmacometrics & Systems Pharmacology ◽

10.1038/psp.2014.45 ◽

2014 ◽

Vol 3 (11) ◽

pp. 1-13 ◽

Cited By ~ 77

Author(s):

A R Maharaj ◽

A N Edginton

Keyword(s):

Drug Development ◽

Modeling And Simulation ◽

Pharmacokinetic Modeling ◽

Physiologically Based Pharmacokinetic Modeling ◽

Pediatric Drug ◽

Pediatric Drug Development ◽

Physiologically Based Pharmacokinetic ◽

Physiologically Based ◽

Pharmacokinetic Modeling And Simulation

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Physiologically Based Pharmacokinetic Modeling in Pediatric Drug Development: A Clinician’s Request for a More Integrated Approach

Journal of Biomedicine and Biotechnology ◽

10.1155/2012/103763 ◽

2012 ◽

Vol 2012 ◽

pp. 1-3 ◽

Cited By ~ 10

Author(s):

Karel Allegaert ◽

Anne Smits ◽

Johannes N. van den Anker

Keyword(s):

Drug Development ◽

Integrated Approach ◽

Pharmacokinetic Modeling ◽

Physiologically Based Pharmacokinetic Modeling ◽

Pediatric Drug ◽

Pediatric Drug Development ◽

Physiologically Based Pharmacokinetic ◽

Physiologically Based

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Physiologically Based Pharmacokinetic Modeling and Allometric Scaling in Pediatric Drug Development: Where Do We Draw the Line?

The Journal of Clinical Pharmacology ◽

10.1002/jcph.1834 ◽

2021 ◽

Vol 61 (S1) ◽

Author(s):

Trevor N. Johnson ◽

Alice B. Ke

Keyword(s):

Drug Development ◽

Allometric Scaling ◽

Pharmacokinetic Modeling ◽

Physiologically Based Pharmacokinetic Modeling ◽

Pediatric Drug ◽

Pediatric Drug Development ◽

Physiologically Based Pharmacokinetic ◽

Physiologically Based

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Incorporating Ontogeny in Physiologically Based Pharmacokinetic Modeling to Improve Pediatric Drug Development: What We Know About Developmental Changes in Membrane Transporters

The Journal of Clinical Pharmacology ◽

10.1002/jcph.1489 ◽

2019 ◽

Vol 59 (S1) ◽

Cited By ~ 3

Author(s):

Kit Wun Kathy Cheung ◽

Bianca D. Groen ◽

Gilbert J. Burckart ◽

Lei Zhang ◽

Saskia N. Wildt ◽

...

Keyword(s):

Drug Development ◽

Pharmacokinetic Modeling ◽

Membrane Transporters ◽

Developmental Changes ◽

Physiologically Based Pharmacokinetic Modeling ◽

Pediatric Drug ◽

Pediatric Drug Development ◽

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 ◽

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 ◽

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 ◽

Cited By ~ 1

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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