The International Council for Harmonisation (ICH) defines distinct age groups relevant to clinical trials and drug development for pediatric populations. These age ranges are used in the ICH E11 guideline to provide recommendations on the clinical investigation of medicinal products in the pediatric population.
Here's a breakdown of the age ranges recognized by the ICH:
- Preterm newborn infants
- Term newborn infants: 0–27 days
- Infants and toddlers: 28 days to 23 months
- Children: 2–11 years
- Adolescents: 12 to 16–18 years (dependent on the region)
It's important to note that the upper limit of the adolescent age range (16-18 years) can vary depending on regional regulations and specific contexts.
