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环境风险评估的监管方法。风险管理建议,合理且审慎的替代方案。

Regulatory approach on environmental risk assessment. Risk management recommendations, reasonable and prudent alternatives.

作者信息

Meisel Maria Leonor, do Céu Costa Maria, Pena Angelina

机构信息

INFARMED, I.P., National Authority of Medicines and Health Products, 1749-004, Lisbon, Portugal.

出版信息

Ecotoxicology. 2009 Nov;18(8):1176-81. doi: 10.1007/s10646-009-0365-7. Epub 2009 Jul 10.

DOI:10.1007/s10646-009-0365-7
PMID:19590955
Abstract

Current knowledge shows that residues of human medicinal products at trace quantities are widespread in aquatic systems. The sewage treatment plants are pointed out as the major source discharge of these compounds on the environment. In this context, it has been worldwide recognised that the environmental impact of medicinal products have to be evaluated, according to recent EU legislation and regulatory guidance. The strategy of the global risk assessment includes primarily a pre-screening based on the estimation of exposure concentrations of drugs in the wastewater. The present paper addresses the decision-maker frontier of the ecologically relevant endpoints. Risk management recommendation and reasonable and prudent alternatives are discussed to minimise the possible environmental impact.

摘要

目前的知识表明,痕量人类药品残留物在水生系统中广泛存在。污水处理厂被指出是这些化合物向环境排放的主要来源。在这种背景下,根据欧盟最近的立法和监管指南,药品对环境的影响必须进行评估这一点已得到全球认可。全球风险评估策略主要包括基于废水中药物暴露浓度估算的预筛选。本文探讨了生态相关终点的决策者前沿问题。讨论了风险管理建议以及合理和审慎的替代方案,以尽量减少可能的环境影响。

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Environ Sci Technol. 2008 Apr 15;42(8):2805-11. doi: 10.1021/es070344q.
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A national reconnaissance for pharmaceuticals and other organic wastewater contaminants in the United States--II) untreated drinking water sources.美国药品及其他有机废水污染物的全国性调查——II)未处理的饮用水源
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Determination of fluoroquinolone antibiotics in hospital and municipal wastewaters in Coimbra by liquid chromatography with a monolithic column and fluorescence detection.
采用整体柱液相色谱法和荧光检测法测定科英布拉医院及城市废水中的氟喹诺酮类抗生素。
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Determination of fluoroquinolone antibiotics in surface waters from Mondego River by high performance liquid chromatography using a monolithic column.使用整体柱通过高效液相色谱法测定蒙德戈河地表水中的氟喹诺酮类抗生素。
J Sep Sci. 2007 Nov;30(17):2924-8. doi: 10.1002/jssc.200700363.
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Human and environmental risk assessment of pharmaceuticals: differences, similarities, lessons from toxicology.药物的人体与环境风险评估:差异、相似之处及毒理学的经验教训
Anal Bioanal Chem. 2007 Feb;387(4):1259-68. doi: 10.1007/s00216-006-0963-7. Epub 2006 Dec 22.
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Analysis of neutral and basic pharmaceuticals in sewage treatment plants and in recipient rivers using solid phase extraction and liquid chromatography-tandem mass spectrometry detection.采用固相萃取和液相色谱-串联质谱检测法分析污水处理厂及受纳河流中的中性和碱性药物。
J Chromatogr A. 2006 Nov 17;1134(1-2):101-11. doi: 10.1016/j.chroma.2006.08.077. Epub 2006 Sep 22.
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J Chromatogr A. 2006 May 5;1114(1):73-81. doi: 10.1016/j.chroma.2006.02.032. Epub 2006 Mar 3.
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Sci Total Environ. 2006 Aug 1;366(2-3):772-83. doi: 10.1016/j.scitotenv.2005.10.007. Epub 2005 Nov 28.
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