Predictive Performance of Physiology‐Based Pharmacokinetic Dose Estimates for Pediatric Trials: Evaluation With 10 Bayer Small‐Molecule Compounds in Children-Reference-Cited by-同舟云学术

Predictive Performance of Physiology‐Based Pharmacokinetic Dose Estimates for Pediatric Trials: Evaluation With 10 Bayer Small‐Molecule Compounds in Children

Published:2021-06 Issue:S1 Volume:61 Page:
ISSN:0091-2700
Container-title:The Journal of Clinical Pharmacology
language:en
Short-container-title:The Journal of Clinical Pharmacology

Author:

Ince Ibrahim¹,Dallmann André¹,Frechen Sebastian¹,Coboeken Katrin¹,Niederalt Christoph¹,Wendl Thomas¹,Block Michael¹,Meyer Michaela¹,Eissing Thomas¹,Burghaus Rolf¹,Lippert Jörg¹,Willmann Stefan¹,Schlender Jan‐Frederik¹

Affiliation:

1. Pharmacometrics/Modeling and Simulation, Research and Development Pharmaceuticals Bayer AG Germany

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/jcph.1869

Reference66 articles.

1. Application of PBPK modeling and simulation for regulatory decision making and its impact on US prescribing information: an update on the 2018‐2019 submissions to the US FDA's office of clinical pharmacology;Zhang X;J Clin Pharmacol,2020

2. FDA.Pediatric study plans: content of and process for submitting initial pediatric study plans and amended pediatric study plans.https://www.fda.gov/regulatory‐information/search‐fda‐guidance‐documents/pediatric‐study‐plans‐content‐and‐process‐submitting‐initial‐pediatric‐study‐plans‐and‐amended. (2020) Accessed August 12 2020.

3. Development of a physiologically‐based pharmacokinetic model for preterm neonates: evaluation with in vivo data;Claassen K;Curr Pharm Des.,2015

4. Development and evaluation of a generic physiologically based pharmacokinetic model for children;Edginton AN;Clin Pharmacokinet,2006

5. Predictive pediatric modeling and simulation using ontogeny information;Ince I;J Clin Pharmacol.,2019

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