Impact of Physiologically Based Pharmacokinetic Models on Regulatory Reviews and Product Labels: Frequent Utilization in the Field of Oncology-Reference-Cited by-同舟云学术

Impact of Physiologically Based Pharmacokinetic Models on Regulatory Reviews and Product Labels: Frequent Utilization in the Field of Oncology

Published:2017-03-15 Issue:5 Volume:101 Page:597-602
ISSN:0009-9236
Container-title:Clinical Pharmacology & Therapeutics
language:en
Short-container-title:Clin. Pharmacol. Ther.

Author:

Yoshida K¹,Budha N¹,Jin JY¹

Affiliation:

1. Department of Clinical Pharmacology; Genentech Research and Early Development; South San Francisco California USA

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Reference5 articles.

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2. European Medicines Agency Draft guideline on the qualification and reporting of physiologically based pharmacokinetic (PBPK) modelling and simulation http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2016/07/WC500211315.pdf 2016

3. 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

4. Physiologically based pharmacokinetic modeling in regulatory decision-making at the European Medicines Agency;Luzon;Clin. Pharmacol. Ther.,2016

5. Physiologically based pharmacokinetic modeling in drug discovery and development: a pharmaceutical industry perspective;Jones;Clin. Pharmacol. Ther.,2015

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