Module 9 2021

22/03/2021

EXTRAPOLATION TO OTHER USES: PAEDIATRICS?

• EU does not require PIP; justification to paediatric population included in extrapolation report – usually formality • US requires PSP but generally not additional pediatric studies • Canada may require trials specifically to gain paediatric indications

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EXTRAPOLATION REPORT

• Review of all relevant literature • Aetiology • MoA of drug in relation to aetiology and pathology of disease • PK across indications • PD across indications • Data supporting efficacy across indications • Is indication sensitive to detect differences in safety and immunogenicity?

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