Event

Role of In Vitro Dissolution Studies for Predictive Insight into In Vivo Performance

Wednesday, March 12, 2025

Universities at Shady Grove (Rockville, Md.), Building II
M-CERSI
cersi@umd.edu

Mark your calendars to attend a workshop on Role of In Vitro Dissolution Studies for Predictive Insight into In Vivo Performance and Biopharmaceutics Risk Mitigation. The workshop is sponsored by the University of Maryland Center for Excellence in Regulatory Science and Innovation (M-CERSI) and the Food and Drug Administration (FDA).

Date: March 11-12, 2025

Time: TBA 

Location: Universities at Shady Grove (Rockville, Md.), Building II

About the Event

This workshop brings together scientists from regulatory agencies and industry to discuss the role of dissolution testing in identifying and controlling critical bioavailability attributes (CBAs) of solid oral dosage forms. This workshop will cover various approaches used by the innovator and generic industry to justify selection of in vitro dissolution methods for assessing product quality at release and mitigating biopharmaceutics risks in response to changes in CBAs. Participants will present case studies and discuss approaches to identify best practices for developing rational in vitro dissolution methods that can provide predictive insights into in vivo performance. These practices may be implemented to establish clinically relevant quality standards and will help ensure high-quality drug products that maintain safety and efficacy throughout their lifecycle.