CRED Understanding Clinical Development 2024

08/10/2024

Nonclinical aspects

Principle

Nonclinical studies in juvenile animals may teach us something about clinical risk/benefit in children before clinical studies are performed:

• Toxicity to immature organs • Likely paediatric PK characteristics • Implications for dose selection

Practice

Nonclinical studies in juvenile animals are not mandatory in principle

They should be considered if human data and existing animal data do not provide adequate reassurance of safety profile in paediatrics

Scientifically unlikely to be relevant for adolescents aged 12 to <18 years

Despite this, many companies feel that juvenile animal studies are becoming a regulatory expectation

The Organisation for Professionals in Regulatory Affairs

17

ICH E11

Clinical aspects – paediatric subsets

Adolescent

Child

Infant

12 to <18 years

Newborn

2 to <12 years

Pre-term

1 month to <2 years

Alternative age subsets are acceptable where justified

Birth to <28 days

<37 weeks gestation

The Organisation for Professionals in Regulatory Affairs

18

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