“Path towards efficient paediatric formulation development based on partnering with clinical pharmacologists and clinicians, a c4c expert group White paper” has been published by British Journal of Clinical Pharmacology.
Despite regulatory requirements and incentives, paediatric formulations still lag behind adult formulations for medicines used in both adults and children. This is largely due to complexities around the development of acceptable age-appropriate paediatric formulations.
It’s important to make age-appropriate formulations a priority in paediatric subsets which meet their medical needs and multiple factors need to be considered when establishing a development strategy for a new paediatric formulation.
This paper proposes use of a paediatric Quality Target Product Profile (pQTPP) to facilitate early planning and decision making across all teams in paediatric formulation development during the children-centric formulation design for new chemical entities, or to repurpose/reformulate off-patent drugs.
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