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Title:Environmental Assessments to Evaluate Pharmaceutical Risks to Ecologic Systems
Author(s):Soli, Amy
Abstract:Studies have found pharmaceutical products in surface and ground water resources, causing concern over the ecological impacts of these compounds in the environment. In response, regulatory agencies (FDA, EMA, and Health Canada) require an assessment of the potential environmental impact of pharmaceuticals as a component of the registration process for new drug applications. These assessments range from a simple analysis demonstrating that the compound will not pose a threat to the environment to very complex assessments requiring numerous studies. In some cases, the applicant may request a categorical exclusion from environmental testing based upon a low predicted concentration at the point of entry into the aquatic environment or due to intrinsic properties of the compound (e.g., biologics are generally excluded because they are expected to degrade rapidly before or after excretion from the treated patient population). However, other compounds, such as those with estrogenic, androgenic, and thyroid activity are coming under increasing scrutiny with more complex studies being required. This presentation will provide an overview of environmental assessment requirements for pharmaceuticals. A case study will also be presented.
Issue Date:2019-05-21
Series/Report:2019 Emerging Contaminants in the Environment Conference (ECEC19)
Genre:Conference Paper / Presentation
Date Available in IDEALS:2019-05-31

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