What ICH E11(R1): Clinical Investigation of Medicinal Products in the Pediatric Population requires
ICH E11(R1) sets the framework for clinical investigation of medicinal products in the paediatric population (birth to 18 years). The R1 addendum (2017) added specific guidance on extrapolation, modelling and simulation, paediatric formulations, ethical considerations, neonatal studies, and the role of paediatric expertise. The guideline divides the paediatric population into preterm newborns, term newborns (0-27 days), infants and toddlers (28 days to 23 months), children (2-11 years), and adolescents (12-18 years). Compliance supports paediatric drug development programmes per US Pediatric Research Equity Act (PREA) and EU Paediatric Regulation 1901/2006.
Pillar: Pharmaceuticals & Life Sciences · Authority: International Council for Harmonisation (ICH) · Version: 1.0.0 · Last updated:
Primary source: https://database.ich.org/sites/default/files/E11_R1_Addendum.pdf
SHA-256 integrity: f41ee6453b2e4e32eb571a9ac250d1265d2d08c3bbd457df48c0854f81d43bcd
Primary Citations — 5 traced to source
- ICH Harmonised Tripartite Guideline E11(R1) Clinical Investigation of Medicinal Products in the Pediatric Population August 2017
- ICH E11 Clinical Investigation of Medicinal Products in the Pediatric Population July 2000
+ 3 more citations (full bibliography, deterministic workflow, actionable schema and crosswalks) included in the vault unlock — $0.01 via Skyfire / L402 / Direct Base USDC.
Access
- Discovery (free): /api/v1/nodes/ich-e11-r1-clinical-investigation-pediatric-population.json — 6-field metadata
- Vault (full node): /api/v1/vault/nodes/ich-e11-r1-clinical-investigation-pediatric-population.json — full 13-key payload, $0.01 USDC (L402/Skyfire/Direct Base)
- Canonical URL: https://bidda.com/intelligence/ich-e11-r1-clinical-investigation-pediatric-population
- Back to registry: Browse all 10,090 compliance nodes