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Note on paediatric products in PQT Medicines

The development of paediatric formulations for essential medicines has been recognized as a critical step for successful healthcare delivery. However, because the majority of clinical studies conducted during pharmaceutical product development are conducted in adult subjects, the development of paediatric formulations and dosing regimens is not straightforward.

In fact, their development typically requires the use of special design considerations for paediatric clinical trials and the use of additional tools to supplement the available clinical data. Indeed, because of the difficulties associated with collecting data from the paediatric population due to ethical and feasibility-related issues, much of the work related to the development of paediatric dosing regimens and subsequently, selection of strengths for paediatric products, relies heavily on additional design tools such as paediatric extrapolation, and modelling and simulation.

The application of these tools exploits the existing knowledge in the adult and paediatric populations as well as knowledge regarding the characteristics of the active pharmaceutical ingredient (API), the disease pathophysiology, and existing nonclinical data.

For more information, please see below "Note of paediatric products in PQT Medicines"