Active pharmaceutical ingredients (APIs) of medicines for human use can be released to the environment during the manufacturing process, following use by patients or when unused medicines are disposed of in an incorrect manner. As APIs are biologically active compounds, concerns have been raised about the potential effects of APIs in the environment on human and environmental health. Over the past 25+ years, a substantial amount of work has been done to determine the occurrence, fate, effects and resulting risks of APIs in the environment, and regulatory schemes have been developed requiring environmental risk assessments of all new APIs. However, for most APIs currently in use, only limited data are available on environmental risks, and for new APIs, the testing schemes may not always be optimal.
The aim of iPiE therefore is to develop frameworks that utilize information from toxicological studies, pharmacological mode of action and in silico models to support intelligence-based environmental testing of pharmaceuticals in development and to prioritise legacy pharmaceuticals (those authorized prior to the 2006 enactment of the European Medicines Agency requirements) for targeted environmental risk assessment and/or environmental (bio-) monitoring.