{"?xml":{"@version":"1.0"},"edm:RDF":{"@xmlns:dc":"http://purl.org/dc/elements/1.1/","@xmlns:edm":"http://www.europeana.eu/schemas/edm/","@xmlns:wgs84_pos":"http://www.w3.org/2003/01/geo/wgs84_pos","@xmlns:foaf":"http://xmlns.com/foaf/0.1/","@xmlns:rdaGr2":"http://rdvocab.info/ElementsGr2","@xmlns:oai":"http://www.openarchives.org/OAI/2.0/","@xmlns:owl":"http://www.w3.org/2002/07/owl#","@xmlns:rdf":"http://www.w3.org/1999/02/22-rdf-syntax-ns#","@xmlns:ore":"http://www.openarchives.org/ore/terms/","@xmlns:skos":"http://www.w3.org/2004/02/skos/core#","@xmlns:dcterms":"http://purl.org/dc/terms/","edm:WebResource":[{"@rdf:about":"http://www.dlib.si/stream/URN:NBN:SI:doc-WFC8LPEF/7c5dc240-3ef0-4e7d-ae5a-b36de7e1af27/PDF","dcterms:extent":"603 KB"},{"@rdf:about":"http://www.dlib.si/stream/URN:NBN:SI:doc-WFC8LPEF/9b3a22dd-f643-48ec-bd03-81ab1742ef82/TEXT","dcterms:extent":"35 KB"}],"edm:TimeSpan":{"@rdf:about":"2005-2025","edm:begin":{"@xml:lang":"en","#text":"2005"},"edm:end":{"@xml:lang":"en","#text":"2025"}},"edm:ProvidedCHO":{"@rdf:about":"URN:NBN:SI:doc-WFC8LPEF","dcterms:isPartOf":[{"@rdf:resource":"https://www.dlib.si/details/URN:NBN:SI:spr-8ER5ZBJN"},{"@xml:lang":"sl","#text":"Farmacevtski vestnik"}],"dcterms:issued":"2019","dc:creator":["Sollner Dolenc, Marija","Stanojević, Mark"],"dc:format":[{"@xml:lang":"sl","#text":"številka:5"},{"@xml:lang":"sl","#text":"letnik:70"},{"@xml:lang":"sl","#text":"str. 345-354"}],"dc:identifier":["ISSN:0014-8229","COBISSID_HOST:4857201","URN:URN:NBN:SI:doc-WFC8LPEF"],"dc:language":"sl","dc:publisher":{"@xml:lang":"sl","#text":"Slovensko farmacevtsko društvo"},"dc:subject":[{"@xml:lang":"sl","#text":"bioakumulativnost"},{"@xml:lang":"sl","#text":"obstojnost"},{"@xml:lang":"sl","#text":"ocena tveganja za okolje (ERA)"},{"@xml:lang":"sl","#text":"Okolje"},{"@xml:lang":"sl","#text":"predvidena koncentracija v okolju (PEC)"},{"@xml:lang":"sl","#text":"strupenost"},{"@xml:lang":"sl","#text":"Zdravila"}],"dcterms:temporal":{"@rdf:resource":"2005-2025"},"dc:title":{"@xml:lang":"sl","#text":"Ocenjevanje tveganja za okolje za humana zdravila| Environmental risk assessment of medicinal products for human use|"},"dc:description":[{"@xml:lang":"sl","#text":"In November 2018, the European medicines Agency (EmA) issued a draft of revised guideline on the environmental risk assessment of medicinal products for human use. The revised guideline upgrades the first guidelines published in 2006 and provide a more consistent and comprehensive approach to environmental risk assessment. Thus, in terms of greater transparency, a decision tree approach was introduced that clearly illustrates substances properties that trigger the need for its testing and evaluation. At the same time, the guideline defines the risk assessment approach for each environmental compartment more clearly. The revision of a twotiered assessment approach also reduces administrative burden, since the revised guideline provides more detailed technical guidance to applicants and allows the introduction of risk reduction measures in the second phase. The draft guideline also defines the tailored risk assessment approach for potential endocrine active substances and antibiotics. The updated guideline thus provides an improved guidance for environmental risk assessment and introduces more precisely evaluation of the influence of the active substances on development and reproduction as well as on the endocrine system"},{"@xml:lang":"sl","#text":"Evropska agencija za zdravila (EmA) je novembra 2018 izdala osnutek prenovljenih smernic za oceno tveganja za okolje za humana zdravila. Prenovljene smernice nadgrajujejo prvotne smernice iz leta 2006 in zagotavljajo bolj dosleden in celovit pristop k oceni tveganja za okolje. Zaradi večje preglednosti uvajajo pristop odločitvenega drevesa, ki nazorno prikazuje lastnosti učinkovin, za katere se zahteva testiranje in ocenjevanje. Hkrati pa bolj jasno definirajo način ocenjevanja tveganja za vsak del okolja posebej. S posodobitvijo dvostopenjskega pristopa k ocenjevanju zmanjšujejo tudi administrativno breme, saj ponujajo podrobnejše tehnične napotke za izpopolnitev ocene izpostavljenosti ter omogočajo vpeljavo ukrepov za zmanjšanje tveganja v drugi fazi. Prav tako osnutek smernice navaja prilagojen pristop k oceni tveganja za potencialne kemične motilce endokrinega sistema in antibiotike. Prenovljene smernice tako predstavljajo izboljšana navodila za oceno tveganja za okolje in uvajajo bolj natančno proučitev vpliva zdravilnih učinkovin na razvoj in reprodukcijo ter endokrini sistem"}],"edm:type":"TEXT","dc:type":[{"@xml:lang":"sl","#text":"znanstveno časopisje"},{"@xml:lang":"en","#text":"journals"},{"@rdf:resource":"http://www.wikidata.org/entity/Q361785"}]},"ore:Aggregation":{"@rdf:about":"http://www.dlib.si/?URN=URN:NBN:SI:doc-WFC8LPEF","edm:aggregatedCHO":{"@rdf:resource":"URN:NBN:SI:doc-WFC8LPEF"},"edm:isShownBy":{"@rdf:resource":"http://www.dlib.si/stream/URN:NBN:SI:doc-WFC8LPEF/7c5dc240-3ef0-4e7d-ae5a-b36de7e1af27/PDF"},"edm:rights":{"@rdf:resource":"http://rightsstatements.org/vocab/InC/1.0/"},"edm:provider":"Slovenian National E-content Aggregator","edm:intermediateProvider":{"@xml:lang":"en","#text":"National and University Library of Slovenia"},"edm:dataProvider":{"@xml:lang":"sl","#text":"Slovensko farmacevtsko društvo"},"edm:object":{"@rdf:resource":"http://www.dlib.si/streamdb/URN:NBN:SI:doc-WFC8LPEF/maxi/edm"},"edm:isShownAt":{"@rdf:resource":"http://www.dlib.si/details/URN:NBN:SI:doc-WFC8LPEF"}}}}