U.S. flag An official website of the United States government
  1. Home
  2. Drugs
  3. News & Events for Human Drugs
  4. Product Quality Research Institute (PQRI) Workshop: MIDD Approaches in Pediatric Formulation Development - 02/28/2024
  1. News & Events for Human Drugs

Public | Virtual

Event Title
Product Quality Research Institute (PQRI) Workshop: MIDD Approaches in Pediatric Formulation Development
February 28 - 29, 2024


Date:
February 28 - 29, 2024
Day1:
- ET
Day2:
- ET

Workshop Objective

The objective of this workshop is to bring together industry, regulators, and academia to develop strategies to overcome current challenges with pediatric formulation development.

  • Day 1 will focus on in vitro and in silico approaches in support of efficient novel pediatric oral formulation development. Specifically, there will be discussion of the role of biorelevant dissolution and PBBM in pediatric formulation development such that reliable predictions of formulation performance across different age groups as well as absorption mediated drug-drug interactions can be made.
  • Day 2 will highlight current gaps in the understanding of the unique aspects of dosing solid oral formulations to pediatric patients. As such, there will be an emphasis on the need to understand the potential negative impact of dosing pediatric drugs mixed with various soft foods on product quality. Furthermore, potential application of PBBM to assess changes in product quality throughout the lifecycle of the product will be explored.
  • Each day will conclude with small group discussions (‘breakout sessions’) that are moderated by SMEs. The topics of these breakout sessions will be announced prior to the event.

The workshop will address the following key areas: pediatric biorelevant dissolution, formulation optimization, drug absorption in pediatric patients, food effect, and drug product quality with an emphasis on coadministration with foods as well as lifecycle management/SUPAC changes.

Meeting Information

Workshop Dates:  February 28-29, 2024

This virtual workshop is open to anyone interested in developing strategies to overcome challenges with pediatric formulation development, specifically to learn from experts and contribute ideas. To register, visit the PQRI website.

Visit the Workshop website for more information.

For questions regarding this event, contact the PQRI Secretariat at PQRISecretariat@pqri.org. You can also visit the PQRI Website for updates.

 
Back to Top