The Bio-met team is please to make available recently completed guidance intended to be used by both the regulatory and the regulated community to promote common understanding of best practice and the challenges associated with the implementation of bioavailability-based EQS.
The document is intended as a dynamic document that will be updated as application and experience of bioavailabilty-based approaches increase with the European Union and beyond. There are some remaining challenges to their implementation, and these have been highlighted with-in the guidance.
Additionally, also being made available is a Response to Comments (RCOM) document, detailing the comments received from variety of member states and organisations on the guidance produced and how these comments have been addressed.