Recent Utilization of Pediatric Extrapolation and Modeling and Simulation Approaches in Pediatric Drug Development in Japan.

ABSTRACT: In Japan, the percentage of approved drugs with pediatric indications increased to 30% in 2010-2015, but no further increase was observed through 2020. The Ministry of Health, Labor, and Welfare in Japan presented draft future directions to promote pediatric drug development, where the modeling and simulation (M&S) approach was introduced as a tool to support efficacy and safety, utilizing existing data when building a flexible data package for pediatric drug approval. M&S is considered a powerful scientific tool in pediatric drug development using the pediatric extrapolation approach. We examined approval application data packages for pediatric drugs approved in Japan from January 2019 to March 2023, where 95 drug products were identified as pediatric drugs for this survey. Drugs with com

SUBMITTER: Nakashima A 

PROVIDER: S-EPMC12649297 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature