pharmind: Modellierung und Simulation in der pädiatrischen Arzneimittelentwicklung
Published: 2023 年 12 月 21 日
This is the article written in German, published on pharmind.
Children’s physiological functions are different from those of adults due to their growth and maturation processes. The limited availability of clinical trial data involving children makes it challenging to make evidence-based decisions regarding the use of drugs in this population. Research involving children also raises ethical considerations that must be addressed alongside the regulatory requirements for safety and efficacy.
Drug regulatory authorities acknowledge the potential of modeling and simulation in the development of pediatric medications. By using quantitative computer models to extrapolate findings from adult studies, researchers can optimize dosing regimens and facilitate the approval of medicines for children.
This article provides an overview of the ethical and regulatory aspects of pediatric drug development, as well as the role of modeling and simulation in this field.
Authors: Author: Nele Mueller-Plock, PhD, Amy Cheung, PhD, Eva Berglund, PhD, Justin Hay, PhD
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