{"?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-CHAQ04F9/9db916de-56ee-4f0a-b26d-5fdd291a39f8/PDF","dcterms:extent":"1931 KB"},{"@rdf:about":"http://www.dlib.si/stream/URN:NBN:SI:doc-CHAQ04F9/78fa36c5-f276-46ec-9211-85db9ff0900a/TEXT","dcterms:extent":"43 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-CHAQ04F9","dcterms:isPartOf":[{"@rdf:resource":"https://www.dlib.si/details/URN:NBN:SI:spr-8ER5ZBJN"},{"@xml:lang":"sl","#text":"Farmacevtski vestnik"}],"dcterms:issued":"2022","dc:creator":["Klinc, Igor","Sollner Dolenc, Marija"],"dc:format":[{"@xml:lang":"sl","#text":"številka:5"},{"@xml:lang":"sl","#text":"letnik:73"},{"@xml:lang":"sl","#text":"str. 384-394"}],"dc:identifier":["ISSN:0014-8229","COBISSID_HOST:132614147","URN:URN:NBN:SI:doc-CHAQ04F9"],"dc:language":"sl","dc:publisher":{"@xml:lang":"sl","#text":"Slovensko farmacevtsko društvo"},"dc:subject":[{"@xml:lang":"sl","#text":"juvenilne živali"},{"@xml:lang":"sl","#text":"neklinično preskušanje zdravil"},{"@xml:lang":"sl","#text":"pediatrična populacija"},{"@xml:lang":"sl","#text":"Pediatrija"},{"@xml:lang":"sl","#text":"registracija zdravil"},{"@xml:lang":"sl","#text":"smernica ICh S11"},{"@xml:lang":"sl","#text":"Zdravila"},{"@xml:lang":"sl","#text":"zdravstveni domovi"}],"dcterms:temporal":{"@rdf:resource":"2005-2025"},"dc:title":{"@xml:lang":"sl","#text":"Neklinično preverjanje varnosti zdravil, namenjenih pediatrični populaciji| Non-clinical safety testing of medicines intended for the paediatric population|"},"dc:description":[{"@xml:lang":"sl","#text":"In the treatment of paediatric population, doctors are often prescribing medicines which were not registered for children. With such prescribing they take into account the differences in characteristics between adults and children. Such experimenting had some tragic consequences in history. With the change of the regulation within the European Union in the field of a new medicine registration procedure, it's since the year 2007 mandatory to prepare a paediatric investigation plan during the medicine development. Based on that the European medicines agency prepared Guidelines on the need for non-clinical testing in juvenile animals of pharmaceuticals for paediatric indications. Just recently a new harmonized guideline S11 was adopted, which was prepared by The International Council for harmonisation. This paper summarizes the content of the S11 guidelines and the importance of drug testing for the paediatric population"},{"@xml:lang":"sl","#text":"V pediatriji zdravniki pogosto uporabljajo zdravila, ki prvotno niso imela dovoljenja za uporabo pri pediatrični populaciji. Pri tem seveda upoštevajo pomembne razlike med lastnostmi otrok v primerjavi z odraslimi. Tovrstno eksperimentiranje je imelo v preteklosti tudi nekaj tragičnih dogodkov. S spremembo zakonodaje v Evropski uniji se je leta 2007 uveljavila zahteva pri registraciji zdravil, da je treba med razvojem za zdravila pripraviti načrt pediatričnih preiskav. Zaradi tega je najprej nastala smernica Evropske agencije za zdravila, ki obravnava izvajanje nekliničnih raziskav z uporabo juvenilnih živali za zdravila, namenjena pediatrični populaciji. Pred kratkim je stopila v veljavo nova harmonizirana smernica S11, ki jo je pripravil Mednarodni svet za harmonizacijo (ICh). V tem prispevku povzemamo vsebino smernic S11 in pomen preskušanja zdravil za pediatrično populacijo"}],"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-CHAQ04F9","edm:aggregatedCHO":{"@rdf:resource":"URN:NBN:SI:doc-CHAQ04F9"},"edm:isShownBy":{"@rdf:resource":"http://www.dlib.si/stream/URN:NBN:SI:doc-CHAQ04F9/9db916de-56ee-4f0a-b26d-5fdd291a39f8/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-CHAQ04F9/maxi/edm"},"edm:isShownAt":{"@rdf:resource":"http://www.dlib.si/details/URN:NBN:SI:doc-CHAQ04F9"}}}}