Author: [AUTHOR] Published on 11/19/2021 12:00:00 PM

US Food and Drug Administration and the University of Maryland Center of Excellence in Regulatory Science and Innovation Announce a Workshop Entitled “Drug Permeability: Best Practices for Biopharmaceutics Classification System-Based Biowaivers”

The US Food and Drug Administration (FDA) and the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) will host a virtual public workshop entitled “Drug Permeability: Best Practices for Biopharmaceutics Classification System-Based Biowaivers” on December 6, 2021. This workshop will bring together stakeholders from FDA, academia, and industry in a virtual setting to discuss generating and evaluating permeability data to further facilitate the implementation of the Biopharmaceutics Classification System (BCS) and the efficient development of high-quality drug products globally.

The 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. As a result, BCS provides a pathway to avoid unnecessary human studies. Recommendations for BCS-based biowaivers were finalized in 2019 in the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) M9 guidance Biopharmaceutics Classification System-Based Biowaivers (https://go.usa.gov/xeqjA).

Within BCS, the most difficult criterion to establish is that the drug substance is highly permeable, as it requires fundamental human mass-balance or absolute bioavailability studies, or extensive in vitro cell permeability data using a properly validated system. The purpose of this workshop is to discuss the industry, academic, and regulatory experience in generating and evaluating permeability data which will further facilitate the implementation of BCS and the efficient development of high-quality drug products globally.

The date, time, and location of the workshop are as follows:
Date: December 6, 2021
Time: 8:30 AM to 4:20 PM ET
Location: This is a virtual public workshop

This workshop is open to the public; however, registration is required. Persons interested in attending this public workshop must register at: https://bioeumd.wufoo.com/forms/m1vmvf3n0fjkp0c/. The workshop agenda can be found at: https://cersi.umd.edu/event/16683/drug-permeability-best-practices-for-bcs-based-biowaivers. When available, slides and other meeting information will be available at:  https://go.usa.gov/xeTAX. 

In addition to lectures and a panel discussion, this workshop will include parallel breakout 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 hour in duration) will occur at 2:00 p.m. ET and are repeated at 3:00 p.m. ET.  When registering, participants will be able to indicate their two preferred breakout sessions.

Breakout sessions are as follows:

• Breakout session 1: In vitro and in silico intestinal permeability methods
• Breakout session 2: Excipient effects on permeability, do we need to be concerned?
• Breakout session 3: Use of label and literature data to designate permeability class

If you have any additional questions about this workshop, please contact Tracey Lee at OCPWorkshops@fda.hhs.gov.

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This communication was prepared by Office of Clinical Pharmacology, Office of Translational Sciences, CDER, FDA.