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Any change in formulation within a clinical development program requires bridging to ensure that the clinical data generated is relevant for a new formulation. As pediatric formulation development typically follows development of the adult product, this can require bridging of safety and efficacy data from the adult product to the pediatric formulation. This chapter covers the principles of bridging formulations in clinical development and uses case study examples to highlight the pathways that can be taken when using multiparticulate formulations.

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Bridging of Formulations Used During Clinical Development

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  • 发表日期：

    2026年

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  • Norbert Pöllinger

摘要

Any change in formulation within a clinical development program requires bridging to ensure that the clinical data generated is relevant for a new formulation. As pediatric formulation development typically follows development of the adult product, this can require bridging of safety and efficacy data from the adult product to the pediatric formulation. This chapter covers the principles of bridging formulations in clinical development and uses case study examples to highlight the pathways that can be taken when using multiparticulate formulations.