PBPK as a tool in regulatory review-Reference-Cited by-同舟云学术

PBPK as a tool in regulatory review

Published:2012-03 Issue:2 Volume:33 Page:51-52
ISSN:0142-2782
Container-title:Biopharmaceutics & Drug Disposition
language:en
Short-container-title:Biopharm. Drug Dispos.

Author:

Huang Shiew-Mei¹

Affiliation:

1. Office of Clinical Pharmacology, Office of Translational Sciences (OTS), Center for Drug Evaluation and Research (CDER); Food and Drug Administration (FDA); Silver Spring; MD; USA

Publisher

Wiley

Subject

Pharmacology (medical),Pharmaceutical Science,Pharmacology,General Medicine

Reference10 articles.

1. Physiologically-based pharmacokinetics in drug development and regulatory science;Rowland;Annu Rev Pharmacol Toxicol,2011

2. Application of physiologically based pharmacokinetic (PBPK) modeling and simulation in regulatory review;Zhao;Clin Pharmacol Ther,2011

3. The role of physiologically-based pharmacokinetic modeling in regulatory review;Huang;Clin Pharmacol Ther,2012

4. Evaluation of exposure change of non-renally eliminated drugs in patients with chronic kidney disease using physiologically-based pharmacokinetic modeling and simulation;Zhao;J Clin Pharmacol,2012

5. Predicting drug interaction potential by using a physiologically-based pharmacokinetic (PBPK) model: case study of telithromycin, a time-dependent CYP3A inhibitor;Viera;Clin Pharmacol Ther

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