A Survey of Neonatal Pharmacokinetic and Pharmacodynamic Studies in Pediatric Drug Development-Reference-Cited by-同舟云学术

A Survey of Neonatal Pharmacokinetic and Pharmacodynamic Studies in Pediatric Drug Development

Published:2015-08-18 Issue:3 Volume:98 Page:328-335
ISSN:0009-9236
Container-title:Clinical Pharmacology & Therapeutics
language:en
Short-container-title:Clin. Pharmacol. Ther.

Author:

Wang J¹,Avant D²,Green D¹,Seo S¹,Fisher J³,Mulberg AE⁴,McCune SK⁵,Burckart GJ¹

Affiliation:

1. Office of Clinical Pharmacology; Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration; Silver Spring Maryland USA

2. Office of Pediatric Therapeutics; Commissioner's Office, U.S. Food and Drug Administration; Silver Spring Maryland USA

3. Division of Biochemical Toxicology; National Center for Toxicology Research, U.S. Food and Drug Administration; Jefferson Arkansas USA

4. Division of Gastroenterology and Inborn Errors Products; Office of Drug Evaluation III, Center for Drug Evaluation and Research, Silver Spring; Maryland USA U.S. Food and Drug Administration

5. Office of Translational Sciences; Center for Drug Evaluation and Research U.S. Food and Drug Administration; Silver Spring Maryland USA

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Reference22 articles.

1. http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm425885.pdf 2015

2. Clinical pharmacology in neonates and young infants: the benefit of a population-tailored approach;Anker;Expert Rev. Clin. Pharmacol.,2012

3. Neonatal clinical pharmacology;Allegaert;Paediatr. Anaesth.,2014

4. The need for rigorous evidence on medication use in preterm infants: is it time for a neonatal rule?;Davis;JAMA,2012

5. Can we afford it?: Ethical consideration of expensive drug treatment for neonates and infants;Zlotnik Shaul;Clin. Pharmacol. Ther.,2009

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