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Updated: May 16, 2026

Evaluating the Effectiveness of Cancer Drug Sensitization In Vitro and In Vivo
Published on: February 6, 2015
Optimizing drug development of anti-cancer drugs in children using modelling and simulation
Johan G C van Hasselt1, Natasha K A van Eijkelenburg, Jos H Beijnen
1Department of Clinical Pharmacology, Netherlands Cancer Institute; Department of Pharmacy & Pharmacology, Slotervaart Hospital/Netherlands Cancer Institute, Amsterdam, the Netherlands. jgc.vanhasselt@gmail.com
Insights
Modelling and simulation (M&S) can optimize paediatric anti-cancer drug development by improving clinical trial design and analysis. Further M&S applications are needed to enhance drug treatment strategies for children.
Area of Science:
- Pharmacometrics
- Paediatric Drug Development
- Oncology
Background:
- Paediatric drug development faces ethical and practical challenges, especially for anti-cancer agents.
- Modelling and simulation (M&S) offer potential solutions for efficient clinical study design and analysis.
- Population pharmacokinetic (PK) modeling is a key M&S approach in drug development.
Purpose of the Study:
- To review the current application of M&S in paediatric anti-cancer drug development.
- To identify opportunities for M&S to further support paediatric oncology drug development.
- To explore M&S's role in bridging pharmacokinetic data between paediatric and adult populations.
Main Methods:
- A structured literature search was conducted on PubMed.
- Analysis focused on studies utilizing M&S for paediatric anti-cancer drug development.
- Review of population PK modeling applications for optimizing dosing and therapeutic drug monitoring.
Main Results:
- Most identified M&S studies employed population PK modeling to understand variability and optimize dosing.
- Therapeutic drug monitoring strategies were a common focus of M&S applications.
- Prospective M&S applications for pharmacokinetic bridging studies in paediatric oncology are infrequently reported.
Conclusions:
- M&S holds significant potential to enhance the efficiency of paediatric clinical trial design and analysis.
- Opportunities exist for M&S to improve pharmacokinetic bridging between paediatric and adult populations.
- Further development and application of M&S can optimize anti-cancer drug treatment strategies for children.
Abstract:
Modelling and simulation (M&S)-based approaches have been proposed to support paediatric drug development in order to design and analyze clinical studies efficiently. Development of anti-cancer drugs in the paediatric population is particularly challenging due to ethical and practical constraints. We aimed to review the application of M&S in the development of anti-cancer drugs in the paediatric population, and to identify where M&S-based approaches could provide additional support in paediatric drug development of anti-cancer drugs. A structured literature search on PubMed was performed. The majority of identified M&S-based studies aimed to use population PK modelling approaches to identify determinants of inter-individual variability, in order to optimize dosing regimens and to develop therapeutic drug monitoring strategies. Prospective applications of M&S approaches for PK-bridging studies have scarcely been reported for paediatric oncology. Based on recent developments of M&S in drug development there are several opportunities where M&S could support more informative bridging between children and adults, and increase efficiency of the design and analysis of paediatric clinical trials, which should ultimately lead to further optimization of drug treatment strategies in this population.
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