Drug Permeability: Best Practices for BCS-based Biowaivers
Monday, December 6, 2021
8:30 a.m.-4:15 p.m.
Collaborative workshop hosted by the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) and the Food and Drug Administration (FDA)
Biopharmaceutics Classification System (BCS) is a well-established scientific framework based on solubility and permeability of the drug substance, plus dissolution of the drug product, and provides assurance of in-vivo bioequivalence based on extensive in-vitro comparative characterization; thus, BCS provides a pathway to avoid unnecessary human studies. BCS was finalized in 2019 as the ICH M9 guidance (https://database.ich.org/sites/default/files/M9_Guideline_Step4_2019_1116.pdf). Within BCS, the most difficult criterion to establish is that the drug substance is highly permeable since this requires fundamental human studies like mass-balance or absolute bioavailability, or extensive in-vitro cell permeability data using a properly validated system. This workshop will provide the venue to thoroughly discuss the industry, academic and regulatory experience in generating and evaluating permeability data which will further facilitate implementation of BCS and efficient development of high-quality drug products globally.
In addition to lectures and a panel discussion, this workshop will include parallel break out sessions on permeability methods, excipient effects, and use of label and literature, respectively. These breakout sessions aim to allow attendees to comment on scientific issues. These breakout sessions (1 hr in duration) will occur at 2pm ET and are repeated at 3pm ET. When registering, participants will be able to indicate their two preferred breakout sessions.
Breakout session are:
- In vitro and in silico intestinal permeability methods
- Excipient effects on permeability, do we need to be concerned?
- Use of label and literature data to designate permeability class
Please see separate documents for further information about these breakout sessions