Event
Drug Dissolution in Oral Drug Absorption Workshop
Tuesday, May 23, 2023
8:30 a.m.-4:30 p.m.
In person: Pharmacy Hall, University of Maryland Baltimore
cersi@umd.edu
The U.S. Food and Drug Administration (FDA)- in collaboration with the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI)- will host a two-day in-person workshop entitled “Drug Dissolution in Oral Drug Absorption” on Tuesday, May 23 and Wednesday, May 24, 2023.
The aim of this two-day workshop is to facilitate dialogue between academic, industrial, and regulatory drug development scientists about current phenomena and methods in oral drug product dissolution. This workshop provides a forum for experts from regulatory agencies, innovator and generic drug industry, consultants, and academia, to focus on contemporary dissolution concepts, methods to anticipate oral drug product dissolution, and recent advancements in dissolution method development beyond compendial approaches. The workshop will include morning presentations on the advances of drug dissolution.
Afternoon breakout sessions will provide the opportunity to deep dive into current challenges/limitations and bring forth emerging approaches and techniques for complex formulations.
Topics:
A. In vivo dissolution and drug absorption
B. In vivo GIT imaging and dynamics
C. Regulatory considerations for Dissolution Method Development (focus on non-
compendial methods)
D. Critical amorphous solid dispersion (ASD) properties and dissolution method
development
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This workshop is supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award U01FD005946 totaling $5,000 with 100 percent funded by FDA/HHS. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by FDA/HHS, or the U.S. Government.
