{"?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-D4BP23YS/e66ae61c-8f74-411d-93b5-0352044c06f1/PDF","dcterms:extent":"196 KB"},{"@rdf:about":"http://www.dlib.si/stream/URN:NBN:SI:doc-D4BP23YS/11e0b0a5-376f-4845-8530-f71d1e80fd60/TEXT","dcterms:extent":"21 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-D4BP23YS","dcterms:isPartOf":[{"@rdf:resource":"https://www.dlib.si/details/URN:NBN:SI:spr-8ER5ZBJN"},{"@xml:lang":"sl","#text":"Farmacevtski vestnik"}],"dcterms:issued":"2017","dc:creator":["Kragelj Lapanja, Nevenka","Sollner Dolenc, Marija"],"dc:format":[{"@xml:lang":"sl","#text":"številka:1"},{"@xml:lang":"sl","#text":"letnik:68"},{"@xml:lang":"sl","#text":"str. 32-37"}],"dc:identifier":["ISSN:0014-8229","COBISSID_HOST:4305521","URN:URN:NBN:SI:doc-D4BP23YS"],"dc:language":"sl","dc:publisher":{"@xml:lang":"sl","#text":"Slovensko farmacevtsko društvo"},"dc:subject":[{"@xml:lang":"en","#text":"drug"},{"@xml:lang":"en","#text":"exposure limits of medicinal products residues"},{"@xml:lang":"en","#text":"LOAEL"},{"@xml:lang":"en","#text":"manufacturing facilities"},{"@xml:lang":"sl","#text":"mejne vrednosti ostankov zdravil"},{"@xml:lang":"en","#text":"NOAEL"},{"@xml:lang":"en","#text":"PDE"},{"@xml:lang":"sl","#text":"proizvodni prostori"},{"@xml:lang":"sl","#text":"Zdravila"},{"@rdf:resource":"http://www.wikidata.org/entity/Q409469"}],"dcterms:temporal":{"@rdf:resource":"2005-2025"},"dc:title":{"@xml:lang":"sl","#text":"Mejne vrednosti ostankov zdravilnih učinkovin in pomožnih snovi po čiščenju v proizvodnih prostorih| Exposure limits of residues of active ingredients and excipients after cleaning in production facilities|"},"dc:description":[{"@xml:lang":"sl","#text":"When producing different medicinal products in shared facilities or equipment, the potential for cross-contamination is a concern. To prevent the effect of contaminants to the effectiveness and/or safety of medicines, the manufacturing equipment needs to be cleaned regularly and the carry-over limits for cleaning validation studies need to be adequately determined. In 2014, an EMA 'Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities' (EMA/CHMP/ CVMP/ SWP/169430/2012) was published. The guideline describes an approach to review and evaluate pharmacological and toxicological data of individual active substances and thus enable determination of threshold levels. The derivation of such a threshold should be based on the use of PDE and ADE. However, other scientifically justified approaches can be used. One of them is the approach that is based on the use of occupational safety data. This article summarises the differences in setting the exposure limits between the two approaches, as well as between the PDE approach and approach used before EMA guideline. The approach in line with EMA guideline is considered more appropriate to establish appropriate exposure limits. In some cases, however, the old method is still suitable, or even more conservative than the new approach"},{"@xml:lang":"sl","#text":"Pri proizvodnji različnih zdravil v istih objektih ali na isti opremi lahko pride do prenosa zdravilne učinkovine ali drugih sestavin farmacevtskega izdelka v naslednji izdelek. Da bi preprečili negativen vpliv na učinkovitost in/ali varnost zdravila, moramo izvajati redno čiščenje proizvodne opreme, vrednosti ostankov zdravilnih učinkovin in pomožnih snovi po čiščenju pa ustrezno zamejiti. Leta 2014 izdana smernica EMA za določanje mejnih vrednosti pri izdelavi različnih zdravil v skupnih objektih (EMA/CHMP/ CVMP/SWP/169430/2012) opisuje pristop določitve mejne vrednosti na podlagi pregleda in vrednotenja farmakoloških in toksikoloških podatkov posameznih zdravilnih učinkovin. Kot osnovo za izračun varnih mej smernica EMA navaja principa dovoljene in sprejemljive dnevne izpostavljenosti, možna pa je tudi uporaba drugih znanstveno utemeljenih pristopov. Eden izmed pristopov je uporaba podatkov, ki so bili pridobljeni za oceno varnosti delavcev. V članku prikazujemo razlike v določanju mejne vrednosti ostankov zdravil ali pomožnih snovi med obema pristopoma, kot tudi med pristopom dovoljene dnevne izpostavljenosti in pristopom, ki se je uporabljal pred izdajo smernice EMA. Čeprav je stara metoda za nekatere primere povsem ustrezna ali celo bolj konservativna od novega pristopa, je pristop v skladu s smernico EMA bolj primeren za določitev mejnih vrednosti zdravilnih učinkovin"}],"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-D4BP23YS","edm:aggregatedCHO":{"@rdf:resource":"URN:NBN:SI:doc-D4BP23YS"},"edm:isShownBy":{"@rdf:resource":"http://www.dlib.si/stream/URN:NBN:SI:doc-D4BP23YS/e66ae61c-8f74-411d-93b5-0352044c06f1/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-D4BP23YS/maxi/edm"},"edm:isShownAt":{"@rdf:resource":"http://www.dlib.si/details/URN:NBN:SI:doc-D4BP23YS"}}}}