{"?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-DCWIEVHI/ddef690c-58c8-46c3-8632-78505c8be97d/HTML","dcterms:extent":"26 KB"},{"@rdf:about":"http://www.dlib.si/stream/URN:NBN:SI:doc-DCWIEVHI/dfb92920-ddf5-4b66-80ff-04b499b74330/PDF","dcterms:extent":"129 KB"},{"@rdf:about":"http://www.dlib.si/stream/URN:NBN:SI:doc-DCWIEVHI/2cc45b3f-82e0-41ae-9b05-cf8e2c5c38a5/TEXT","dcterms:extent":"24 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-DCWIEVHI","dcterms:isPartOf":[{"@rdf:resource":"https://www.dlib.si/details/URN:NBN:SI:spr-8ER5ZBJN"},{"@xml:lang":"sl","#text":"Farmacevtski vestnik"}],"dcterms:issued":"2011","dc:creator":["Ekar, Petra","Mrhar, Aleš","Zajc-Kreft, Katarina"],"dc:format":[{"@xml:lang":"sl","#text":"številka:4"},{"@xml:lang":"sl","#text":"letnik:62"},{"@xml:lang":"sl","#text":"str. 179-183"}],"dc:identifier":["ISSN:0014-8229","COBISSID:3132785","URN:URN:NBN:SI:doc-DCWIEVHI"],"dc:language":"sl","dc:publisher":{"@xml:lang":"sl","#text":"Slovensko farmacevtsko društvo"},"dc:subject":[{"@xml:lang":"sl","#text":"farmakodinamične študije"},{"@xml:lang":"sl","#text":"klinične študije"},{"@xml:lang":"sl","#text":"lokalno delujoča zdravila"},{"@xml:lang":"sl","#text":"študije in vitro"},{"@xml:lang":"sl","#text":"terapevtska ekvivalenca"}],"dcterms:temporal":{"@rdf:resource":"2005-2025"},"dc:title":{"@xml:lang":"sl","#text":"Terapevtska ekvivalenca lokalno delujočih zdravil| Therapeutic equivalence of locally acting medicinal products|"},"dc:description":[{"@xml:lang":"sl","#text":"Therapeutic equivalence of systemically acting medicinal products for human use is most often established by comparison of pharmacokinetic profiles for the test and the reference product. In case of locally acting medicinal products the presumption that plasma or urine profiles reflect the delivery to the site of action, is most often not appropriate. Other approaches used forestablishing therapeutic equivalence in that case are phase III clinical studies, pharmacodynamic studies, in vitro studies and other appropriate methods, depending on more or less specific regulatory requirements. Comparative clinical studies are, in contrast to pharmacokinetic (bioequivalence) studies which are most often connected to concept of therapeutic equivalence, larger, more time consuming, complex and costly"},{"@xml:lang":"sl","#text":"Terapevtsko ekvivalenco sistemsko delujočih zdravil za humano uporabo najpogosteje dokazujemo s primerjavo farmakokinetičnih profilov učinkovine testnega in primerjalnega zdravila. Pri lokalno delujočih zdravilih predpostavka, da plazemski oziroma urinski profili odsevajo dostavo učinkovine na mestu delovanja, navadno ni primerna. V ta namen pri lokalno delujočih zdravilih izvajamo klinične študije faze III, farmakodinamične študije, študije in vitro ter druge ustrezne metode, odvisno od bolj ali manj specifičnih regulatornih zahtev. Primerjalne klinične študije so v nasprotju s farmakokinetičnimi (bioekvivalenčnimi) študijami, ki jih najpogosteje povezujemo z dokazovanjem terapevtske ekvivalence, obsežnejše, dolgotrajnejše, kompleksnejše in dražje"}],"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-DCWIEVHI","edm:aggregatedCHO":{"@rdf:resource":"URN:NBN:SI:doc-DCWIEVHI"},"edm:isShownBy":{"@rdf:resource":"http://www.dlib.si/stream/URN:NBN:SI:doc-DCWIEVHI/dfb92920-ddf5-4b66-80ff-04b499b74330/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-DCWIEVHI/maxi/edm"},"edm:isShownAt":{"@rdf:resource":"http://www.dlib.si/details/URN:NBN:SI:doc-DCWIEVHI"}}}}