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.

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