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Volumn 45, Issue 3, 2006, Pages 223-228

The environmental risk assessment of human pharmaceuticals in the overall EU regulatory affairs process

Author keywords

Assessment strategy; Environmental risk assessment; Interdisciplinary evaluation

Indexed keywords

ARTICLE; DRUG EFFICACY; DRUG SAFETY; ECONOMIC ASPECT; ECOTOXICOLOGY; ENVIRONMENT; ENVIRONMENTAL PROTECTION; EUROPEAN UNION; EVALUATION; PRIORITY JOURNAL; RISK ASSESSMENT; RISK BENEFIT ANALYSIS; RISK MANAGEMENT;

EID: 33746001404     PISSN: 02732300     EISSN: 10960295     Source Type: Journal    
DOI: 10.1016/j.yrtph.2006.04.001     Document Type: Article
Times cited : (11)

References (10)
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    • EMEA, 2005a. Press Release: EMEA Conference on Environmental Risk Assessment for Human and Veterinary Medicinal Products, 27-28 October 2005. .
  • 3
    • 33745975489 scopus 로고    scopus 로고
    • EMEA, 2005b. Guideline on the environmental risk assessment of medicinal products for human use. CHMP/SWP/4447/00 draft, London, 20 January 2005. .
  • 4
    • 33746024639 scopus 로고    scopus 로고
    • European Union, 1993. Directive 93/39/EEC of 14 June 1993 amending Directive 65/65/EEC, 75/318/EEC, and 75/319/EEC in respect of medicinal products. Off J, L214, 22-30, 24 August 1993.
  • 5
    • 33746023655 scopus 로고    scopus 로고
    • European Union, 2001. Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the community code relating to medicinal products for human use. Off J, L311, 67-128, 28 November 2001.
  • 6
    • 33746011238 scopus 로고    scopus 로고
    • European Union, 2004. Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the community code relating to medicinal products for human use. Off J, L136, 34-57, 30 April 2004.
  • 7
    • 2342652328 scopus 로고    scopus 로고
    • A theoretical model for utilizing mammalian pharmacology and safety data to prioritise potential impacts of human pharmaceuticals to fish
    • Huggett D.B., Cook J.C., Ericsson J.F., and Williams R.T. A theoretical model for utilizing mammalian pharmacology and safety data to prioritise potential impacts of human pharmaceuticals to fish. Hum. Ecol. Risk Assess. 9 (2003) 1780-1790
    • (2003) Hum. Ecol. Risk Assess. , vol.9 , pp. 1780-1790
    • Huggett, D.B.1    Cook, J.C.2    Ericsson, J.F.3    Williams, R.T.4
  • 8
    • 33746001952 scopus 로고    scopus 로고
    • ICH, 2004. Harmonised Tripartite Guideline. Organisation of the Common Technical Document for the Registration of Pharmaceuticals for Human Use. International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use. .
  • 9
    • 33746030305 scopus 로고    scopus 로고
    • Kern, K., 2005. Environmental effects of medicines-status and needs for reforms. Deutsches Verwaltungsblatt DVBL, 1 February 2005, 153-160 (in German).
  • 10
    • 0037052834 scopus 로고    scopus 로고
    • Environmental risk assessment of pharmaceutical drug substances-conceptual considerations
    • Länge R., and Dietrich D. Environmental risk assessment of pharmaceutical drug substances-conceptual considerations. Toxicol. Lett. 131 (2002) 97-104
    • (2002) Toxicol. Lett. , vol.131 , pp. 97-104
    • Länge, R.1    Dietrich, D.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.