![]() ![]() However, changes in physiology during paediatric development may have substantial impact on drug pharmacokinetics (PK) and pharmacodynamics (PD) 2. 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.ĭrug treatment in the paediatric population is still frequently off-label, with dosing regimens commonly empirically derived from adult clinical trial data 1. ![]() Prospective applications of M&S approaches for PK-bridging studies have scarcely been reported for paediatric oncology. 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. A structured literature search on PubMed was performed. 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. Development of anti-cancer drugs in the paediatric population is particularly challenging due to ethical and practical constraints. ![]() Modelling and simulation (M&S)-based approaches have been proposed to support paediatric drug development in order to design and analyze clinical studies efficiently. ![]()
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |