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

Gilbert J Burckart1, Susan Abdel-Rahman2, Caleb Choi2

  • 1Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Bldg 51 Rm 3184, 10903 New Hampshire Ave, Silver Spring, Maryland, 20903, USA. gilbert.burckart@fda.hhs.gov.

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Summary
This summary is machine-generated.

Model-informed drug development (MIDD) advances pediatric formulation. New biorelevant models improve drug absorption predictions for pediatric patients, aiding regulatory submissions.

Keywords:
bioequivalencebiorelevantoral formulationspediatricsphysiologically-based biopharmaceutics modeling

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Area of Science:

  • Pharmacology and Pharmaceutical Sciences
  • Drug Development
  • Pediatric Medicine

Background:

  • Pediatric formulation development requires understanding ontogeny-related processes affecting drug interactions.
  • Current methods for pediatric drug absorption modeling need enhancement for accuracy.

Purpose of the Study:

  • To review advancements in Model-Informed Drug Development (MIDD) for pediatric formulations.
  • To discuss novel biorelevant models and their application in pediatric drug development.
  • To identify knowledge gaps in pediatric absorptive processes.

Main Methods:

  • Virtual workshop on MIDD approaches in pediatric formulation development.
  • Discussion of dissolution testing and its role in modeling pediatric drug absorption.
  • Review of pediatric biorelevant models and physiologically based modeling.

Main Results:

  • Progress has been made in understanding ontogeny-related processes influencing pediatric drug formulation.
  • Pediatric biorelevant models offer more realistic dissolution data for pediatric patients.
  • These models aid in generating data for regulatory submissions.

Conclusions:

  • MIDD approaches are crucial for advancing pediatric formulation development.
  • Enhanced biorelevant and physiologically based models improve drug absorption predictions.
  • Further research into pediatric absorptive processes is needed for optimized formulations.