Paediatric product development is the development of age appropriate formulations. Traditional drug development has predominantly focused on the development of drug products for an adult population, which has led to the off-label use of conventional dosage forms in paediatrics. This often involved manipulating the dosage form (i.e. cutting tablets or opening capsules) to enable delivery to children and infants bringing unknown safety issues.
Recent changes in the regulations framework now requires the pharmaceutical industry to design and develop age appropriate formulations and perform clinical trials involving paediatrics, in addition to the development and approval of the drug product for adults. Inadequate progress in the paediatric product assessment can lead to delays or rejection of the approval for the primary adult indication.
Seda offers a service that is unique in this landscape. A complete handover and transformation of your molecule by providing end-to-end CMC and regulatory support and consultancy for paediatric product development including:
- An understanding of the global regulations on paediatric development
- Guidance on development, selection and/or appropriateness of the formulation being developed for
the designated age range - Guidance on excipient selection e.g. GRAS (Generally Regarded As Safe), paediatric specific.
- Identification and management of CDMO/CRO with experience in manufacturing paediatric
formulations and devices - Sourcing and management of taste masking technologies from third party contract service providers
- Biopharmaceutical assessment of paediatric products including bridging between adult and
paediatric formulations - PK-PD modelling of all paediatric age groups
- Recommendations on regulatory strategies and authoring & reviews of PIPs (Paediatric Investigation Plans)
Our PK modelling services can also be useful to translate knowledge from one population to another e.g. from adult to paediatric.
