Extractables and leachables predictive modeling for pharmaceutical products risk management: A call for broader regulatory acceptance.

Modeling approaches for determination of extractables and leachables in (bio)pharmaceutical products are a growing area of applied technology and innovation. Modeling, to support predictions related to leachables (migrants) levels, is applied in food packaging and medical devices, and has established pathways for regulatory acceptance in these sectors. Regulatory acceptance is less established for pharmaceutical / biotechnology products. The Extractables and Leachables Safety Information Exchange (ELSIE) consortium has developed this manuscript to provide scientific, technical and regulatory impetus for further acceptance of these approaches in regulatory agencies globally through examples and discussion of how modeling can be applied in this area.