Model-Based Assessment of Dosing Strategies in Children for Monoclonal Antibodies Exhibiting Target-Mediated Drug Disposition-Reference-Cited by-同舟云学术

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Model-Based Assessment of Dosing Strategies in Children for Monoclonal Antibodies Exhibiting Target-Mediated Drug Disposition

Published:2014-10 Issue:10 Volume:3 Page:138
ISSN:2163-8306
Container-title:CPT: Pharmacometrics & Systems Pharmacology
language:en
Short-container-title:CPT: Pharmacometrics & Systems Pharmacology

Author:

Zheng S¹,Gaitonde P¹,Andrew M A²,Gibbs M A³,Lesko L J¹,Schmidt S¹

Affiliation:

1. Center for Pharmacometrics and Systems Pharmacology; University of Florida; Orlando Florida USA

2. Department of Pharmacokinetics and Drug Metabolism; Amgen; Seattle Washington USA

3. Department of Pharmacokinetics and Drug Metabolism; Amgen; Thousand Oaks California USA

Publisher

Wiley

Subject

Pharmacology (medical),Modeling and Simulation

Link

http://onlinelibrary.wiley.com/wol1/doi/10.1038/psp.2014.38/fullpdf

Reference46 articles.

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

2. FDA Safety and Innovation Act 2012 http://www.gpo.gov/fdsys/pkg/BILLS-112s3187enr/pdf/BILLS-112s3187enr.pdf

3. Drug development for pediatric populations: regulatory aspects;Zisowsky;Pharmaceutics,2010

4. Proposals for model-based paediatric medicinal development within the current European Union regulatory framework;Manolis;Br. J. Clin. Pharmacol.,2009

5. Clinical pharmacology and the catalysis of regulatory science: opportunities for the advancement of drug development and evaluation;Zineh;Clin. Pharmacol. Ther.,2013

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