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. 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 served as a venue in which 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 included parallel breakout sessions on permeability methods, excipient effects, and use of label and literature, respectively. These breakout sessions allowed attendees to comment on scientific issues. These breakout sessions (1 hr in duration) were held at 2 p.m. ET and repeated at 3 p.m. ET. When registering, participants were able to indicate their two preferred breakout sessions.
Breakout session topics:
- 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