Abstract
Children are not small adults, and the pharmacokinetics and pharmacodynamics (PK/PD) of a drug in children are often different from those in adults. Therefore, efficacy, safety and dosage should be carefully evaluated in every age group that will most likely benefit from the drug. Although there is a certain degree of accumulated knowledge in developmental pharmacology that is briefly described in this paper, it is still difficult to accurately estimate the PK/PD of drugs in children. Therefore, clinical trials should be conducted on each drug. Many drugs which are approved in the EU and/or the US are still off-labeled in Japan because of the lack of clinical trial data in Japanese children. There have been several critical actions taken by the Ministry of Health, Labour and Welfare to promote pediatric drug development, and physicians, governments and industries must work together to further promote pediatric drug development.
