Bioequivalence and Bioavailability Forum

Good afternoon Marcel!

❝ Anyone aware of the state of the BCS as it concerns extended-release formulations? Is there any regulatory movement on this?

❝ Can someone suggest any good articles that deals with the BCS and extended-release formulatons?

By definition the BCS is only applicable to immediate relase formulations. Or to be more precise: For IR products marketing authorization may be granted based on in vitro studies alone. If it comes to MR-formulations, you will need to perform at least one conventional in vivo study, and may apply for biowaivers for different strenghts - given the conditions in guidelines (proportionality of contents of API, excipients, etc.).