Volume 49, Issue 8 p. 889-904

The In Silico Child: Using Simulation to Guide Pediatric Drug Development and Manage Pediatric Pharmacotherapy

Dr Stephanie Läer MD, PhD

Corresponding Author

Dr Stephanie Läer MD, PhD

Department of Clinical Pharmacy and Pharmacotherapy, Heinrich-Heine University, Düsseldorf, Germany

Address for correspondence: Stephanie Läer, MD, PhD, Department of Clinical Pharmacy and Pharmacotherapy, Heinrich-Heine-University of Düsseldorf, 40225 Düsseldorf, Germany; e-mail: [email protected].Search for more papers by this author
Dr Jeffrey S. Barrett PhD, FCP

Dr Jeffrey S. Barrett PhD, FCP

Division of Clinical Pharmacology & Therapeutics, The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania

Search for more papers by this author
Dr Bernd Meibohm PhD, FCP

Dr Bernd Meibohm PhD, FCP

Department of Pharmaceutical Sciences, College of Pharmacy, University of Tennessee Health Science Center, Memphis, Tennessee

Search for more papers by this author
First published: 07 March 2013
Citations: 60

All authors contributed equally to the manuscript. This manuscript is based on a workshop of the Hexal Children's Medication Initiative ([email protected]) titled “The In Silico Child: Can We Calculate Children?” held at Heinrich-Heine-University of Düsseldorf, Germany, February 14–15, 2008.

Abstract

Significant gains have been made in the appreciation of pediatrics as an important population in which rationale pharmacotherapy guidance is warranted but often currently lacking. Although the regulatory framework for major improvements in pediatric drug development was implemented in Europe a decade later than the United States, recent efforts, including the 2007 “Better Medicines for Children” initiative, indicate that the awareness of this problem is indeed a global phenomenon. Nevertheless, there still remains a gap between the awareness and the implementation of rationale and scientifically based drug development and applied pharmacotherapy in children. Specifically, a vision of how best to move from empiricism toward a plan that incorporates biologic knowledge about the maturation of physiologic processes as well as the drug- and disease-specific knowledge generated from drug development and applied pharmacotherapy in adults must evolve from the present intentions. Modeling and simulation approaches can facilitate such a vision that ultimately should provide benefit to pediatric patients. Although recent examples of pediatric in silico approaches are compelling, their ultimate value may be in the identification of data and studies that better guide drug therapy and in the education of pediatric caregivers to the principles of clinical pharmacology that underlie optimal pharmacotherapeutic decisions in children.