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What is an Environmental Risk Assessment for a Pharmaceutical Compound? — A Global Overview

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Interest over the potential for pharmaceuticals in the environment to impact human health and the environment is international in scope. Consequently, several nations of the world have developed formalized regulations and frameworks to assess the potential impacts posed by pharmaceuticals in the environment. The existing regulations typically require that environmental fate and effects (toxicity) testing be carried out to support the development of an environmental risk assessment. The environmental risk assessment is included in the marketing applications for drugs and vaccines along with the standard data on product safety, efficacy, and quality. If a potential risk is identified, the results of the risk assessment can be used by industry and regulatory authorities to develop strategies to manage the risk. This presentation will present the regulatory frameworks, risk assessment strategies, and environmental testing requirements required to develop an environmental risk assessment for a pharmaceuticals compound in the United States, the European Union, and Canada.

Document Type: Research Article


Publication date: January 1, 2008

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  • Proceedings of the Water Environment Federation is an archive of papers published in the proceedings of the annual Water Environment Federation® Technical Exhibition and Conference (WEFTEC® ) and specialty conferences held since the year 2000. These proceedings are not peer reviewed.

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