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- W1511436216 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." @default.
- W1511436216 created "2016-06-24" @default.
- W1511436216 creator A5000418012 @default.
- W1511436216 creator A5025499001 @default.
- W1511436216 creator A5060294217 @default.
- W1511436216 creator A5062227574 @default.
- W1511436216 creator A5090770279 @default.
- W1511436216 date "2013-06-20" @default.
- W1511436216 modified "2023-10-05" @default.
- W1511436216 title "Optimizing drug development of anti-cancer drugs in children using modelling and simulation" @default.
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