CRED Understanding Clinical Development 2024

08/10/2024

Capturing PIP strategy – a useful tool

Adolescents

Aspect of PIP

Pre-term Neonates

Infants

Children

PIP condition

PIP indication(s)

Waiver

Age-appropriate formulation

Juvenile animal studies

Clinical

Modelling & simulation

Extrapolation

Deferral

The Organisation for Professionals in Regulatory Affairs

23

Capturing PIP strategy – a useful tool

Adolescents

Aspect of PIP

Pre-term Neonates Infants

Children

PIP condition

Treatment of cough

PIP indications

Treatment of dry cough; treatment of post-viral cough

Does not occur

Waiver

No significant benefit

No waiver available

Age-appropriate formulation Juvenile animal studies

Develop oral liquid

Use adult formulation

1 rat tox study relevant for children aged ≥2 years

No

One age-staggered clinical trial in children aged 2 to <17 years. Age cohorts 12 to <18, 6 to <12 and 2 to <6 years.

Clinical

Not required due to waiver request

Modelling & simulation

Yes. Objective is to identify likely optimum dose(s) in advance of paediatric clinical trial.

Extrapolation

No

Request deferral for completion of oral liquid development and juvenile animal study. Request for initiation and completion of modelling exercise and paediatric clinical trial.

Deferral

The Organisation for Professionals in Regulatory Affairs

24

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