Paediatric medicine development
A unique, patient centric service that manages the development of age appropriate medicines
Traditional drug development has predominantly focused on the development of drug products for an adult population, which 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.
The changes in the regulations in the development of medicines for paediatrics now require 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.
Seda offer 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 medicine 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 (GRAS, paediatric specific/safety)
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
Why choose Seda?
In house expertise
Seda’s team of experts has several years of experience in the design of age appropriate formulations with a sound understanding of the additional considerations involved in the development of paediatric medicines. In addition, Seda’s Lab facilities are based at Alderley Park where we conduct rapid screening of formulation prototypes including dissolution testing to provide a rapid, responsive and pragmatic service that will accelerate the development of your clinical formulation. In silico predictive PK and PK/PD models are developed in house to define paediatric doses and/or dosing schedules.
An extensive network of associates
By partnering and collaborating with other key paediatric specialists we are able to field the team of diverse associates with paediatric expertise that are needed in order to provide such a unique end to end service. These are high profile, internationally recognised experts with a track record of success across a wide range of paediatric development projects. Couple this with the best pharmaceutical science input that is traditionally associated with SEDA and you have a best in world solution.
For more information or to arrange an initial consultation please email: