InVitro Dissolution Studies for Predictive Insight into InVivo Performance

Registration Fees

• $800 - general attendees

• $300 - government attendees (must have an email ending in ".gov" in order to register at this rate)

• For faculty and students from the University of Maryland, Baltimore; The Universities at Shady Grove; University of Maryland, College Park; and University of Maryland, Baltimore County; Please contact us at ([email protected]) and indicate which workshop you are interested in.

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.

Workshop Topics

Day 1: Dissolution Method Development, Control of CBAs, and In Vitro Drug Release Product Specifications for Immediate Release Solid Oral Dosage Products

Day 2: Dissolution Method Development, Control of CBAs, and In Vitro Drug Release Product Specifications for Extended Release Solid Oral Dosage Products

Funding

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 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.

Agenda

Day 1: Dissolution Method Development, Control of CBAs, and In Vitro Drug Release Product Specifications for Immediate Release Solid Oral Dosage Products

Session 1: Introduction and Objectives

Session 2: Gaps/Challenges in Dissolution Method Development and Spec Settings

Breakout Sessions

Day 2: Dissolution Method Development, Control of CBAs, and In Vitro Drug Release Product Specifications for Extended Release Solid Oral Dosage Products

Session 3: Gaps/Challenges in Dissolution Method Development and Spec Settings for Extended Release Products

Breakout Sessions

Additional information and the agenda can be found at: https://www.Ph*rm*cy.umaryland.edu/centers/cersievents/2025dissolution/

Host or Publisher M-CERSI