Environmental risk determination algorithm for veterinary medicinal products
The environmental risk analysis for veterinary medicinal products is an assessment of their possible evolution, exposures and effects and is structured according to the EMEA/CVMP/ERA/418282/2005-Rev1[1], VICH GL6 (Phase I) and GL38 (Phase II) guides. The three primary components of a quantitative ri...
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| Format: | Article |
| Language: | English |
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Asociaţia Naţională a Fabricanţilor de Produse de Uz Veterinar
2019-12-01
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| Series: | Medicamentul Veterinar |
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| Online Access: | http://www.veterinarypharmacon.com/docs/2075-2019_VD_13(2)_ART3_ENG.pdf |
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| _version_ | 1849412818648956928 |
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| author | Viviana Ciuca Viorel V. Safta Romeo T. Cristina |
| author_facet | Viviana Ciuca Viorel V. Safta Romeo T. Cristina |
| author_sort | Viviana Ciuca |
| collection | DOAJ |
| description | The environmental risk analysis for veterinary medicinal products is an assessment of their possible evolution, exposures and effects and is structured according to the EMEA/CVMP/ERA/418282/2005-Rev1[1], VICH GL6 (Phase I) and GL38 (Phase II) guides. The three primary components of a quantitative risk assessment are: exposure assessment, effects assessment, and risk characterization. Based on the indication of use of the veterinary medicinal product, the exposure assessment begins with the release of the active substance into the environment, and while taking into account the drug's fate and distribution, develops a predicted environmental concentration (PEC). The effects assessment begins with toxicity data and applies an assessment factor (AF) to it resulting in a predicted no effect concentration (PNEC). The risk characterization includes development of a risk quotient (RQ) that is calculated by dividing the PEC by the PNEC. If RQ ≥1 assessment moves to next tier. The paper presents an algorithm for calculating the initial risk for soil, groundwater, surface water and sediment under the action of the active ingredient in the analyzed veterinary medicinal product. Based on this calculation algorithm, a specialized interactive software has been developed to allow rapid and convenient determination of environmental risk for veterinary medicinal products. It is a very useful tool for environmental risk assessment specialists. |
| format | Article |
| id | doaj-art-05d13a33cd7c4b8ea51c61b7a11ff470 |
| institution | Kabale University |
| issn | 1843-9527 2069-2463 |
| language | English |
| publishDate | 2019-12-01 |
| publisher | Asociaţia Naţională a Fabricanţilor de Produse de Uz Veterinar |
| record_format | Article |
| series | Medicamentul Veterinar |
| spelling | doaj-art-05d13a33cd7c4b8ea51c61b7a11ff4702025-08-20T03:34:20ZengAsociaţia Naţională a Fabricanţilor de Produse de Uz VeterinarMedicamentul Veterinar1843-95272069-24632019-12-011322227Environmental risk determination algorithm for veterinary medicinal productsViviana Ciuca0Viorel V. Safta1Romeo T. Cristina2NS Pasteur Institute SA, BucharestPolytechnic University of BucharestFaculty of Veterinary Medicine TimisoaraThe environmental risk analysis for veterinary medicinal products is an assessment of their possible evolution, exposures and effects and is structured according to the EMEA/CVMP/ERA/418282/2005-Rev1[1], VICH GL6 (Phase I) and GL38 (Phase II) guides. The three primary components of a quantitative risk assessment are: exposure assessment, effects assessment, and risk characterization. Based on the indication of use of the veterinary medicinal product, the exposure assessment begins with the release of the active substance into the environment, and while taking into account the drug's fate and distribution, develops a predicted environmental concentration (PEC). The effects assessment begins with toxicity data and applies an assessment factor (AF) to it resulting in a predicted no effect concentration (PNEC). The risk characterization includes development of a risk quotient (RQ) that is calculated by dividing the PEC by the PNEC. If RQ ≥1 assessment moves to next tier. The paper presents an algorithm for calculating the initial risk for soil, groundwater, surface water and sediment under the action of the active ingredient in the analyzed veterinary medicinal product. Based on this calculation algorithm, a specialized interactive software has been developed to allow rapid and convenient determination of environmental risk for veterinary medicinal products. It is a very useful tool for environmental risk assessment specialists.http://www.veterinarypharmacon.com/docs/2075-2019_VD_13(2)_ART3_ENG.pdfenvironmentriskalgorithm |
| spellingShingle | Viviana Ciuca Viorel V. Safta Romeo T. Cristina Environmental risk determination algorithm for veterinary medicinal products Medicamentul Veterinar environment risk algorithm |
| title | Environmental risk determination algorithm for veterinary medicinal products |
| title_full | Environmental risk determination algorithm for veterinary medicinal products |
| title_fullStr | Environmental risk determination algorithm for veterinary medicinal products |
| title_full_unstemmed | Environmental risk determination algorithm for veterinary medicinal products |
| title_short | Environmental risk determination algorithm for veterinary medicinal products |
| title_sort | environmental risk determination algorithm for veterinary medicinal products |
| topic | environment risk algorithm |
| url | http://www.veterinarypharmacon.com/docs/2075-2019_VD_13(2)_ART3_ENG.pdf |
| work_keys_str_mv | AT vivianaciuca environmentalriskdeterminationalgorithmforveterinarymedicinalproducts AT viorelvsafta environmentalriskdeterminationalgorithmforveterinarymedicinalproducts AT romeotcristina environmentalriskdeterminationalgorithmforveterinarymedicinalproducts |