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<p>In February of 2024, the Product Quality Research Institute held a virtual workshop entitled “Model-Informed Drug Development (MIDD) Approaches in Pediatric Formulation Development.” The workshop covered a range of topics related to pediatric formulation development and testing, including dissolution testing and applications to modeling drug absorption in developing pediatric patients. Workshop speakers reviewed the progress that has been made to advance our understanding of ontogeny related processes that drive interactions with product formulations and inform pediatric product development. They discussed recently constructed pediatric biorelevant models that provide more realistic information about drug dissolution in pediatric patients and their use in physiologically based models to produce data for regulatory submissions. Despite the progress, opportunities remain to expand the fund of knowledge on pediatric absorptive processes that will support the development of pediatric-friendly drug formulations.</p> Graphical Abstract <p></p>

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PQRI Workshop: Model-Informed Drug Development (MIDD) Approaches in Pediatric Formulation Development

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2026年3月9日

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  • Gilbert J. Burckart,
  • Susan Abdel-Rahman,
  • Caleb Choi,
  • M. Petrea Cober,
  • James E. Cummins Jr.,
  • Nikoletta Fotaki,
  • Daniel Gonzalez,
  • David Harris,
  • Neil Parrott,
  • Hardikkumar Patel,
  • Fang Wu,
  • Andreas Abend

摘要

In February of 2024, the Product Quality Research Institute held a virtual workshop entitled “Model-Informed Drug Development (MIDD) Approaches in Pediatric Formulation Development.” The workshop covered a range of topics related to pediatric formulation development and testing, including dissolution testing and applications to modeling drug absorption in developing pediatric patients. Workshop speakers reviewed the progress that has been made to advance our understanding of ontogeny related processes that drive interactions with product formulations and inform pediatric product development. They discussed recently constructed pediatric biorelevant models that provide more realistic information about drug dissolution in pediatric patients and their use in physiologically based models to produce data for regulatory submissions. Despite the progress, opportunities remain to expand the fund of knowledge on pediatric absorptive processes that will support the development of pediatric-friendly drug formulations.

Graphical Abstract