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- W4387300019 abstract "Abstract Introduction The number of medicinal products labelled for paediatric use is limited. Regulatory measures to promote paediatric drug development in the US and Europe and the establishment of an international guideline (ICH-E11) have led to an increase in the number of paediatric labels. In Japan, efforts have been made to promote the development of paediatric drugs. This study was to examine whether paediatric drug development is being promoted, and whether off-label drug use by children is decreasing in Japan. Methods This study examined the number of new drugs approved for paediatric indications in Japan from 2006 to 2021, as well as the clinical data package, that is, characteristics of the approved paediatric drugs and paediatric clinical trials, and the percentage of extrapolation of adult data, in the most recent five-year period. Results The number of paediatric drug approvals underwent a temporary increase between 2006 and 2012. The proportion of drugs indicated for paediatric patients to the total number of approved drugs did not change markedly during the survey period, indicating that off-label use did not decrease. Simultaneous development in adults and children has increased, but the extrapolation of adult data to paediatric populations has not been widely utilized. Conclusions In Japan, the number of paediatric drug approvals has shown a slight upward trend but has not yet reached the point of significantly reducing off-label use. Appropriate development strategies, such as the extrapolation of adult data to paediatric populations, should be considered." @default.
- W4387300019 created "2023-10-04" @default.
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- W4387300019 creator A5062032148 @default.
- W4387300019 date "2023-10-03" @default.
- W4387300019 modified "2023-10-04" @default.
- W4387300019 title "Paediatric drug development in Japan: A study over the past 15 years" @default.
- W4387300019 doi "https://doi.org/10.21203/rs.3.rs-3322635/v1" @default.
- W4387300019 hasPublicationYear "2023" @default.
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