PQRI Workshop: MIDD Approaches in Pediatric Formulation Development
A Virtual Event – Wednesday – Thursday, February 28-29, 2024
Registration is closed.
PQRI is hosting a virtual workshop – MIDD Approaches in Pediatric Formulation Development on February 28-29, 2024.
Key Speakers from FDA, Academia, and Industry
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.
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- 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.
Workshop Materials
A Workshop flyer is available for download and sharing with your interested colleagues.
A final program is available (as of 2/26/24).
Speaker bios are available here.
Presentations
Presentations will be available for registered attendees only. (Registered attendees will receive a password from the Conference Organizers.) Click here to access the presentations.
Questions
Please contact the PQRI Secretariat if you have any questions at +1(202) 230-5607 or PQRISecretariat@pqri.org.