Приказ основних података о документу

dc.creatorIlić, Nina
dc.creatorSavić, Snežana
dc.creatorSiegel, Evan
dc.creatorAtkinson, Kerry
dc.creatorTasić, Ljiljana
dc.date.accessioned2019-09-02T11:28:41Z
dc.date.available2019-09-02T11:28:41Z
dc.date.issued2012
dc.identifier.issn2157-6564
dc.identifier.urihttps://farfar.pharmacy.bg.ac.rs/handle/123456789/1690
dc.description.abstractA wide range of regulatory standards applicable to production and use of tissues, cells, and other biologics (or biologicals), as advanced therapies, indicates considerable interest in the regulation of these products. The objective of this study was to analyze and compare high-tier documents within the Australian, European, and U.S. biologic drug regulatory environments using qualitative methodology. Eighteen high-tier documents from the European Medicines Agency (EMA), U.S. Food and Drug Administration (FDA), and Therapeutic Goods Administration (TGA) regulatory frameworks were subject to automated text analysis. Selected documents were consistent with the legal requirements for manufacturing and use of biologic drugs in humans and fall into six different categories. Concepts, themes, and their co-occurrence were identified and compared. The most frequent concepts in TGA, FDA, and EMA frameworks were "biological," "product," and "medicinal," respectively. This was consistent with the previous manual terminology search. Good Manufacturing Practice documents, across frameworks, identified "quality" and "appropriate" as main concepts, whereas in Good Clinical Practice (GCP) documents it was "clinical," followed by "trial," "subjects," "sponsor," and "data." GCP documents displayed considerably higher concordance between different regulatory frameworks, as demonstrated by a smaller number of concepts, similar size, and similar distance between them. Although high-tier documents often use different terminology, they share concepts and themes. This paper may be a modest contribution to the recognition of similarities and differences between analyzed regulatory documents. It may also fill the literature gap and provide some foundation for future comparative research of biologic drug regulations on a global level. STEM CELLS TRANSLATIONAL MEDICINE 2012;1:909-920en
dc.publisherWiley, Hoboken
dc.rightsopenAccess
dc.sourceStress-The International Journal on the Biology of Stress
dc.subjectCellular therapyen
dc.subjectClinical translationen
dc.subjectClinical trialsen
dc.subjectEthicsen
dc.titleExamination of the Regulatory Frameworks Applicable to Biologic Drugs (Including Stem Cells and Their Progeny) in Europe, the US, and Australia: Part II-A Method of Software Documentary Analysisen
dc.typearticle
dc.rights.licenseARR
dcterms.abstractТасић, Љиљана; Сиегел, Еван; Илић, Нина; Aткинсон, Керрy; Савић, Снежана;
dc.citation.volume1
dc.citation.issue12
dc.citation.spage909
dc.citation.epage920
dc.citation.other1(12): 909-920
dc.citation.rankM23
dc.identifier.wos000312823200006
dc.identifier.doi10.5966/sctm.2012-0038
dc.identifier.pmid23283552
dc.identifier.scopus2-s2.0-84872946357
dc.identifier.fulltexthttps://farfar.pharmacy.bg.ac.rs//bitstream/id/511/1688.pdf
dc.type.versionpublishedVersion


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Приказ основних података о документу