Recent Utilization of Pediatric Extrapolation and Modeling and Simulation Approaches in Pediatric Drug Development in Japan.
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...
| Publicado en: | Journal of Clinical Pharmacology Vol. 65; no. 12; pp. 1889 - 1900 |
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| Autores principales: | , , , , , |
| Formato: | research tables/charts Journal Article |
| Publicado: |
Wiley-Blackwell
Dec2025
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=189709630&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 189709630 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 00912700 5WH jtl: Journal of Clinical Pharmacology issn: 00912700 maglogo: Y pubinfo: dt: Dec2025 vid: 65 iid: 12 pid: 480 pub: Wiley-Blackwell place: Malden, Massachusetts artinfo: ui: 189709630 187336864 189709630 189709630 10.1002/jcph.70091 189709630 ppf: 1889 ppct: 11 formats: tig: atl: Recent Utilization of Pediatric Extrapolation and Modeling and Simulation Approaches in Pediatric Drug Development in Japan. aug: au: Nakashima, Akinori Tsujimoto, Akihide Saito, Masako Takeda, Jun Natori, Makiko Shoji, Satoshi affil: Japan Pharmaceutical Manufacturers Association Clinical Evaluation Expert Committee, Drug Evaluation Committee, Tokyo, Japan sug: subj: Drug Development In Infancy and Childhood Drug Design Utilization Simulations Utilization Drug Approval Government Regulations Drugs, Investigational Human Secondary Analysis Japan Surveys Drug Efficacy Patient Safety Clinical Trials Infant Dosage Calculation Drug Administration Descriptive Statistics Funding Source Infant: 1-23 months ab: 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 complete, partial, or no extrapolation accounted for 43.2%, 30.5%, and 26.3% of the total drugs, respectively. M&S was widely used as the major rationale in dose selection for pediatric clinical trials and/or the recommended dosing regimen in drug approval applications for the pediatric population (60.0%). Further use of existing data with extrapolation strategies may lead to the development of flexible and efficient data packages for pediatric drug approval. Since safety profiles may be different between pediatric and adult populations due to age‐related factors, pediatric developmental safety should be incorporated into M&S in future assessments. The pharmaceutical industry, regulatory authorities, and academia need to discuss development strategies from an early stage and share lessons learned, thereby facilitating further discussions on efficient pediatric drug development and delivering drugs for children without delay in Japan. pubtype: Academic Journal doctype: research tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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