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

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

doi:10.1208/s12248-026-01217-y

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

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

Research output: Contribution to journal › Article › peer-review

Abstract

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.

Original language	English
Article number	68
Journal	AAPS Journal
Volume	28
Issue number	2
Early online date	9 Mar 2026
DOIs	https://doi.org/10.1208/s12248-026-01217-y
Publication status	Published - 9 Mar 2026

Data Availability Statement

All of the presentations and slides from the workshop are freely available via the PQRI website (1).

Funding

All authors except for DG received no specific financial support for the research, authorship, and/or publication of this article. Dr. Gonzalez receives support from the Eunice Kennedy Shriver National Institute of Child Health and Human Development and other sponsors for drug development in adults and children (https://dcri.org/about-us/conflict-of-interest/).

Keywords

bioequivalence
biorelevant
oral formulations
pediatrics
physiologically-based biopharmaceutics modeling

ASJC Scopus subject areas

Pharmaceutical Science

Access to Document

10.1208/s12248-026-01217-yLicence: CC BY

Cite this

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title = "PQRI Workshop: Model-Informed Drug Development (MIDD) Approaches in Pediatric Formulation Development",

abstract = "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.",

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AU - Burckart, Gilbert J.

AU - Abdel-Rahman, Susan

AU - Choi, Caleb

AU - Cober, M. Petrea

AU - Cummins, James E.

AU - Fotaki, Nikoletta

AU - Gonzalez, Daniel

AU - Harris, David

AU - Parrott, Neil

AU - Patel, Hardikkumar

AU - Wu, Fang

AU - Abend, Andreas

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AB - 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.

KW - bioequivalence

KW - biorelevant

KW - oral formulations

KW - pediatrics

KW - physiologically-based biopharmaceutics modeling

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ER -

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

Abstract

Data Availability Statement

Funding

Keywords

ASJC Scopus subject areas

Access to Document

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