The Evolution of Biopharmaceutics: Risk Assessment and Clinical Relevance

The in-person workshop is sponsored by the University of Maryland Center for Excellence in Regulatory Science and Innovation (M-CERSI) & FDA

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 (cersi@umd.edu) and indicate which workshop you are interested in.

About the Event

This two-day public workshop represents a transformative approach towards the role of dissolution testing in regulatory decision making, moving beyond traditional quality control paradigms toward a predictive, patient-centric science. The workshop will explore the importance of dissolution testing and its shift from a quality control test to strategic tool that ensures adequate clinical performance throughout changes in the drug product’s lifecycle.

The workshop centers on a comprehensive risk assessment framework that examines the interplay between API physicochemical properties, drug product attributes, and gastrointestinal physiological conditions. This framework ranks drug products from very low to very high risk based on how material attributes and formulation and manufacturing variables, along with gastrointestinal physiological conditions, influence in vivo drug dissolution and absorption into the systemic circulation. In this context, the risk level determines the appropriate dissolution testing strategy and regulatory requirements.

Participants will explore how this paradigm shift can improve product understanding, reduce regulatory burden, and assure consistent clinical performance of moderate- to high-risk drug products by aligning dissolution testing with actual patient outcomes rather than arbitrary specifications or process capabilities.

Workshop Session Scopes

Session 1: Biopharmaceutics Risk Assessment Framework

Scope: This foundational session establishes the core framework that connects dissolution testing to pharmacokinetic profiles. Presentations will cover how API physicochemical properties and drug product CBAs interact with gastrointestinal physiological conditions (pH, food effects, GI tract mobility) to determine in vivo dissolution and absorption. The session will demonstrate how this understanding enables the development of dissolution tests that are indicative of bioperformance rather than simply ensuring batch-to-batch consistency.

Session 2: High Risk Drug Products - IVIVC and IVIVR

Scope: This session focuses on products where rate and extent of drug absorption are dictated by in vivo drug release. Discussions will cover mitigation strategies including PK studies to establish IVIVRs, and when possible validated IVIVCs, the development of "Bioequivalence Safe Spaces," and the supplementary role of Physiologically Based Biopharmaceutics Modeling (PBBM).

Session 3: Medium Risk Drug Products – How to Use Biopharmaceutics Tool to Understand and Mitigate Risk?

Scope: This session addresses products where in vivo dissolution and absorption are governed by drug substance properties and are likely impacted by GI physiological conditions. The focus will be on developing dissolution methods, including biorelevant methods that mimic and may therefore be, indicative of in vivo performance, the potential for these methods to exist separately from QC dissolution methods, and their use in mitigating BA/BE requirements for lifecycle management. Discussions will center on what data and scientific justifications are required to potentially downgrade, rather than just mitigate, the risk from medium to low from a regulatory perspective and therefore, reduce the dissolution testing requirements throughout the product’s lifecycle.

Session 4: Low and Very Low Risk Products - What is Needed and What is Not

Scope: This session examines products where in vivo dissolution is minimally impacted by formulation variables or GI conditions. For very low-risk products, discussions will explore the potential for waiving dissolution testing for batch release. For low-risk products, the session will cover how simple dissolution tests are sufficient to ensure consistent PK performance and what minimal development data are required.

Session 5: The Future of Dissolution - Beyond Quality Control

Scope: This forward-looking session explores the evolution toward predictive, patient-centric standards including Clinically Relevant Dissolution Specifications (CRDS) and the concept of "safe space" dissolution ranges where bioequivalence is assured. Discussions will cover the totality-of-evidence approach, the vision for harmonized global regulatory frameworks where scrutiny is proportional to biopharmaceutical risk, and how enhanced biopharmaceutics understanding represents a strategic investment yielding cost savings and development efficiency.

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.

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