Bottom-up Meets Top-down: Complementary Physiologically Based Pharmacokinetic and Population Pharmacokinetic Modeling for Regulatory Approval of a Dosing Algorithm of Valganciclovir in Very Young Children-Reference-Cited by-同舟云学术

Bottom-up Meets Top-down: Complementary Physiologically Based Pharmacokinetic and Population Pharmacokinetic Modeling for Regulatory Approval of a Dosing Algorithm of Valganciclovir in Very Young Children

Published:2016-09-29 Issue:6 Volume:100 Page:761-769
ISSN:0009-9236
Container-title:Clinical Pharmacology & Therapeutics
language:en
Short-container-title:Clin. Pharmacol. Ther.

Author:

Jorga K¹,Chavanne C²,Frey N²,Lave T³,Lukacova V⁴,Parrott N³,Peck R²,Reigner B²

Affiliation:

1. KarinJorga Life Science Consulting GmbH; Basel Switzerland

2. Pharma Research & Development, Clinical Pharmacology, Roche Innovation Center Basel; F. Hoffmann-La Roche Ltd; Basel Switzerland

3. Pharma Research & Development, Pharmaceutical Sciences, Roche Innovation Center Basel; F. Hoffmann-La Roche Ltd; Basel Switzerland

4. SimulationsPlus, Inc.; Lancaster California USA

Funder

F. Hoffmann-La Roche Ltd

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Reference50 articles.

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2. U.S. Food and Drug Administration Amendments Act (FDAAA) of 2007 Public Law 110-85. Title IV: Pediatric Research Equity Act of 2007 and Title V: Best Pharmaceuticals for Children Act of 2007. http://www.fda.gov/RegulatoryInformation/Legislation/SignificantAmendmentstotheFDCAct/FoodandDrugAdministrationAmendmentsActof2007/FullTextofFDAAALaw/default.htm 2007

3. Population pharmacokinetic studies in pediatrics: issues in design and analysis;Meibohm;AAPS J.,2005

4. Optimizing pediatric dosing: a developmental pharmacologic approach;Anderson;Pharmacotherapy,2009

5. What is the right dose for children?;Cella;Br. J. Clin. Pharmacol.,2010

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