Workshop on the Use of Modeling and Monitoring in the Environmental Risk Assessment of Human Medicines
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Richard Murray-Smith AstraZeneca Global Safety, Health, and Environment, Brixham Environmental Laboratory, Brixham, UK Maria Ramil German Federal Institute of Hydrology (BfG), Koblenz, Germany
Correspondence Address Richard Murray-Smith, AstraZeneca Global Safety, Health, and Environment, Brixham Environmental Laboratory, Brixham, Devon TQ5 8BA, UK (e-mail: Richard.murray-smith @astrazeneca.com).
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Workshop on the Use of Modeling and Monitoring in the Environmental Risk Assessment of Human Medicines
THE ISSUE This workshop explored the role of modeling and monitoring in the environmental risk assessment (ERA) of human medicines. In particular, it explored when modeling and monitoring should be undertaken and how the results should be used. The imminent launch of the new European Medicines Agency (EMEA) guideline in the European Union (1) inevitably provided a focus for discussions, and the main overriding conclusion was that further guidance is needed in the following key areas: Use of data: To define what data can be used for predicting adsorption to sludge and soil, bioaccumulation and degradation (biotic and abiotic), and, most importantly, to provide guidance on how such data can be used in models. Particular attention is needed to address the use and misuse of Kow for predicting the fate of complex ionic molecules, which are characteristic of many APIs (active pharmaceutical ingredients). Use of models: Identify which models can be used to make better use of higher tier studies, such as the test for Aerobic and Anaerobic Transformation in Aquatic Sediment Systems (Organization for Economic Cooperation and Development [OECD] test guideline 308) Interpretation: Guide appropriate interpretation of predicted environmental concentrations (PECs) and measured environmental concentrations
(MECs); guide appropriate use of probabilistic (eg, 90th percentile values) versus deterministic PECs and MECs in ERA Use of monitoring data: Provide more detailed guidance on the amount of data needed and where monitoring should be undertaken for an MEC to override a PEC What to do if PEC:PNEC is greater than 1 or if a PBT (persistent, bioaccumulative, and toxic) or vPvB (very persistent and very bioaccumulative) substance is identified: Provide further information and guidance on higher tier models and analytical methods that can be used to refine the ERA and how such tools can be used
Last, there was general agreement on the need to continue to review the suitability and applicability of the EMEA testing recommendations (1), particularly at phase II, tier A, as we gain experience with the new guidance.
WORKSHOP OBJECTIVES The purpose of this parallel workshop was to explore the roles of exposure modeling and monitoring in the context of ERA of human pharmaceuticals. Modeling is effectively the only option for new pharmaceuticals prior to marketing approval, but for established products it may be possible to measure actual concentrations in the environment and to utilize more sophisticated exposure modeling techniques. The
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