Summary of Workshop on Use of Data Developed during Drug Development for Read across to Environmental Analyses

The chemistry; primary and secondary pharmacodynamics (eg, mechanism of action and pharmacological actions unrelated to the therapeutic effect); pharmacokinetics (absorption, distribution, metabolism, and excretion); and in vitro and animal toxicology of human pharmaceuticals are extensively studied during preregistration discovery and development. [...] utilizing data that support the medical use of a pharmaceutical to answer environmental questions or guide the development of environmental data has potential benefits that include minimizing (eg, not duplicating) animal testing and enhancing the focus and effectiveness of the environmental risk assessment.