{"?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-JXZQ1MPK/ab983b0c-cf52-4c64-ae1f-263570a7d432/PDF","dcterms:extent":"1710 KB"},{"@rdf:about":"http://www.dlib.si/stream/URN:NBN:SI:doc-JXZQ1MPK/d64f211f-d32c-4b26-923a-62004e58fe85/TEXT","dcterms:extent":"42 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-JXZQ1MPK","dcterms:isPartOf":[{"@rdf:resource":"https://www.dlib.si/details/URN:NBN:SI:spr-8ER5ZBJN"},{"@xml:lang":"sl","#text":"Farmacevtski vestnik"}],"dcterms:issued":"2024","dc:creator":["Klemenc, Nejc","Zorec, Barbara","Zvonar Pobirk, Alenka"],"dc:format":[{"@xml:lang":"sl","#text":"številka:1"},{"@xml:lang":"sl","#text":"letnik:75"},{"@xml:lang":"sl","#text":"str. 43-54"}],"dc:identifier":["ISSN:0014-8229","COBISSID_HOST:196360195","URN:URN:NBN:SI:doc-JXZQ1MPK"],"dc:language":"sl","dc:publisher":{"@xml:lang":"sl","#text":"Slovensko farmacevtsko društvo"},"dc:subject":[{"@xml:lang":"en","#text":"critical material attributes"},{"@xml:lang":"en","#text":"critical process parameters"},{"@xml:lang":"en","#text":"critical quality attributes"},{"@xml:lang":"sl","#text":"Dostavni sistemi"},{"@xml:lang":"sl","#text":"kritične lastnosti vhodnih materialov"},{"@xml:lang":"sl","#text":"kritični atributi kakovosti"},{"@xml:lang":"sl","#text":"kritični procesni parametri"},{"@xml:lang":"en","#text":"liposomes"},{"@xml:lang":"sl","#text":"liposomi"},{"@xml:lang":"en","#text":"quality by design"},{"@xml:lang":"sl","#text":"vgrajena kakovost"}],"dcterms:temporal":{"@rdf:resource":"2005-2025"},"dc:title":{"@xml:lang":"sl","#text":"Razvoj dostavnih sistemov na osnovi liposomov z vgrajeno kakovostjo| Development of liposomal delivery systems by quality by design approach|"},"dc:description":[{"@xml:lang":"sl","#text":"With the increasing intensity of research and development in the field of liposomes as delivery systems, reflected in numerous regulatory approved products, the broad applicability of these systems is evident. however, due to the complex nature of liposomal formulations, it is crucial to approach the development of such pharmaceutical products thoughtfully. An effective strategy for managing this complexity is the quality by design (QbD) approach, which focuses on understanding the formulation, process and product based on scientific evidence, while effectively managing potential risks. To identify critical factors and optimize both formulations and processes, a systematic and planned approach to experimental design is crucial. This approach includes input variables (materials, processes, expeimental design) and considers the key quality characteristics of liposomal formulations. Such a development approach enables us to integrate quality into the product and provide patients with a high quality, safe and effective advanced drug delivery system"},{"@xml:lang":"sl","#text":"Z naraščajočo intenzivnostjo raziskav in razvoja na področju liposomov kot dostavnih sistemov, ki se odraža v številnih s strani regulativnih organov odobrenih izdelkih, se nazorno kaže tudi široka uporabnost teh sistemov. Zaradi kompleksne narave liposomskih formulacij pa je zelo pomembno, da premišljeno pristopamo k razvoju tovrstnih farmacevtskih izdelkov. Kot močna strategija za obvladovanje te kompleksnosti se pojavlja pristop vgrajene kakovosti (QbD), ki poudarja, da sta za nadzor kakovosti ključna tako razumevanje formulacije, procesa in izdelka na osnovi znanstvenih dognanj kot sočasno učinkovito obvladovanje morebitnih tveganj. Za identifikacijo kritičnih dejavnikov in optimizacijo tako formulacij kot procesov je ključen sistematičen in načrtovan pristop k načrtovanju eksperimentov, ki vključuje vhodne spremenljivke (materiali, procesi, načrtovanje eksperimentov) in upošteva ključne atribute kakovosti liposomskih formulacij. Takšen pristop k razvoju nam omogoča, da kakovost vgradimo v izdelek, bolnikom pa nudimo kakovosten, varen in učinkovit napredni dostavni 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-JXZQ1MPK","edm:aggregatedCHO":{"@rdf:resource":"URN:NBN:SI:doc-JXZQ1MPK"},"edm:isShownBy":{"@rdf:resource":"http://www.dlib.si/stream/URN:NBN:SI:doc-JXZQ1MPK/ab983b0c-cf52-4c64-ae1f-263570a7d432/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-JXZQ1MPK/maxi/edm"},"edm:isShownAt":{"@rdf:resource":"http://www.dlib.si/details/URN:NBN:SI:doc-JXZQ1MPK"}}}}