Spring Intro 2023

16/02/2023

It’s not just about clinical trials

• Tablet size • Injection volume • Excipient safety

• Formulation and dosage form are important

• Juvenile animal studies may be needed

• Toxicity to developing organs

• Clinical trials

• Usually a feature but not always

• Modelling & simulation

• Prediction of appropriate paediatric dose(s) by age / weight

• Extrapolation

• Inference of efficacy / safety using data from other age groups

The Organisation for Professionals in Regulatory Affairs

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Capturing PIP strategy – a tool

Aspect of PIP

Pre-term Neonates

Infants

Children Adolescents

PIP condition PIP indication Waiver Age-appropriate formulation Juvenile animal studies Clinical studies Modelling & simulation Extrapolation Deferral

The Organisation for Professionals in Regulatory Affairs

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