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It consists of six structure-related items (dose, adverse drug reactions, drug interactions, overdose, pregnancy\/breast feeding, and pharmacokinetics) according to implicit or explicit references to TDM in paragraphs of the SPC, and four theory-guided items according to the information about ranges of plasma concentrations and a recommendation of TDM in the SPC. The catalogue is regarded as valid for the text analysis of SPCs with respect to TDM. It can be used in the comparison of SPCs, in the comparison with medico-scientific evidence and for the estimation of the perception of TDM in SPCs by the reader. Regarding the approach as a model of text mining, it may be extended for evaluation of other aspects reported in SPCs.<\/p>","DOI":"10.4018\/jkdb.2010040101","type":"journal-article","created":{"date-parts":[[2011,2,15]],"date-time":"2011-02-15T20:02:27Z","timestamp":1297800147000},"page":"1-11","source":"Crossref","is-referenced-by-count":0,"title":["SPCCTDM, a Catalogue for Analysis of Therapeutic Drug Monitoring Related Contents in the Drug Prescription Information"],"prefix":"10.4018","volume":"1","author":[{"given":"Sven","family":"Ulrich","sequence":"first","affiliation":[{"name":"Pharmaceutical Consultant, Germany"}]},{"given":"Pierre","family":"Baumann","sequence":"additional","affiliation":[{"name":"University of Lausanne, Switzerland"}]},{"given":"Andreas","family":"Conca","sequence":"additional","affiliation":[{"name":"Regional Hospital of Bolzano, Italy"}]},{"given":"Hans-Joachim","family":"Kuss","sequence":"additional","affiliation":[{"name":"University of Munich, Germany"}]},{"given":"Viktoria","family":"Stieffenhofer","sequence":"additional","affiliation":[{"name":"University of Mainz, Germany"}]},{"given":"Christoph","family":"Hiemke","sequence":"additional","affiliation":[{"name":"University of Mainz, Germany"}]}],"member":"2432","reference":[{"key":"jkdb.2010040101-0","doi-asserted-by":"publisher","DOI":"10.1055\/s-2004-832687"},{"key":"jkdb.2010040101-1","doi-asserted-by":"publisher","DOI":"10.1007\/s00228-005-0943-4"},{"key":"jkdb.2010040101-2","doi-asserted-by":"publisher","DOI":"10.1177\/001316448104100307"},{"key":"jkdb.2010040101-3","unstructured":"Electronic Medicines Compendium. 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SPCC(TDM): Catalogue for the content analysis of summary of product characteristics (SPCs) with reference to therapeutic drug monitoring (TDM). 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