Active pharmaceutical ingredients (APIs) can be released to the natural 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 2006 enactment of Medicines Agency requirements) for targeted environmental risk assessment and/or environmental (bio) monitoring.
The aim will be delivered through a number of specific objectives:
To review existing approaches for prioritization of APIs and their intelligent testing based on mode of action and to develop improved frameworks for such purposes.
To establish a high quality database on the properties, environmental fate characteristics and ecotoxicity of APIs
To develop methods for estimating external and internal exposure to APIs for different scenarios
To develop methods and models for predicting ecotoxicological responses to APIs
To validate the developed models, concepts and frameworks using targeted experiments
To develop a software system to support intelligent testing and prioritization of APIs in the environment
To develop guidance on how the software system and associated predictive tools can be used
To engage with and exchange knowledge with stakeholder groups throughout the project
These objectives will be delivered by a world leading consortium comprising experts in data management and computational modelling, pharmacology, ecotoxicology, environmental chemistry, predictive (eco)toxicology, prioritization and intelligent testing methodologies and environmental risk assessment.