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In the United States, the assessment of risk to the environment of manufacture, use and distribution of human and animal health drugs is required under the National Environmental Policy Act of 1969. Such assessments are required by the U.S. Food and Drug Administration (FDA) and in Europe by member countries of the European Union as a requirement for the approval of new drug applications (NDAs) or supplements. The environmental risk assessment methodologies published by these agencies are discussed with an assessment of current knowledge of the regulatory status. The environmental exposure pathways of human and animal health drugs are described. The current understanding of fate and effects of human and animal health drugs in the environment and the author's view of risk assessment from a fate and effects approach are also discussed.
human health drugs, animal health drugs, environmental fate, environmental effects, risk assessment, FDA, European Commission
Vice President and director, Analytical Bio-Chemistry Laboratories, Inc., Columbia, MO
Projects Manager, Analytical Bio-Chemistry Laboratories, Inc., Columbia, MO