The unique challenges in pediatric drug development require efficient and innovative tools.
Model‐informed drug development (MIDD) offers many powerful tools that have been …

Abstract Model‐informed drug development (MIDD) has been a powerful and efficient tool
applied widely in pediatric drug development due to its ability to integrate and leverage …

Introduction Off‐label drug use in the paediatric population is common, and the lack of high‐
quality efficacy studies poses patients at risk for failing pharmacotherapy. Next to efficacy …

Extrapolation can be used to address challenges in pediatric drug development. This review
describes how these challenges could be addressed by further evolution of quantitative …

Pharmacodynamic (PD) endpoints are essential for establishing the benefit-to-risk ratio for
therapeutic interventions in children and neonates. This article discusses the selection of an …

Antisecretory drugs are frequently used in the treatment of pediatric gastrointestinal
disorders. This study was aimed to assess the prescribing patterns and the safety of …

Introduction The European Medicines Agency (EMA) offers scientific advice to support the
qualification procedure of novel methodologies, such as preclinical and in vitro models …

The use of mathematical modeling to represent, analyze, make predictions or providing
information on data obtained in drug research and development has made pharmacometrics …

The use of extrapolation of efficacy in pediatric drug development programs is possible
when disease progression and treatment response are similar in adult and pediatric …

Background: We investigated the efficacy of esomeprazole for the treatment of
gastroesophageal reflux disease (GERD) in a meta-analysis of clinical trials results …