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Kontrola kakovosti zdravil v prometu v SlovenijiKočevar Nared, Jasna ...Za zdravila, kot predmete posebnega pomena za celotno družbo, je potrebno pred pridobitvijo dovoljenja za promet dokazati, da so kakovostna, varna in učinkovita. V nasprotnem primeru predstavljajo ... veliko potencialno nevarnost za zdravje prebivalstva. Po sprostitvi zdravil v promet se kakovost nadzoruje z zakonsko določenimi nadzori. V članku je podrobneje predstavljenen izmed zakonsko predpisanih nadzorov nad kakovostjo zdravil v Sloveniji - redna kontrola kakovosti zdravil v prometu. Način izvajanja rednekontrole kakovosti zdravil v prometu je primerljiv z nadzorom v evropskemprostoru in omogoča celovit in neodvisen nadzor registriranih zdravil v Republiki Sloveniji. Pokriva vse segmente distribucije zdravil, kar daje vpogled v realno sliko kakovosti zdravil. Iz opravljenih preskušenj v okviru redne kontrole kakovosti zdravil v letu 2002 smo za 3,9 % zdravil ugotovili odstope od specifikacij, ki določajo kakovost registriranega zdravila. K celoviti kakovosti zdravila prispeva tudi spremljajoča oprema in pisna informacija na ovojnini in v navodilu za uporabo. Visok, kar 80 % delež neskladnosti glede označevanja, strokovnega izrazoslovja in nedoslednosti pri navedbi informacij na ovojnini, navodilu za uporabo ter veljavni dokumentaciji zdravila, kaže, da proizvajalce zdravil na tem področju oeaka še veliko dela.Source: Farmacevtski vestnik : strokovno glasilo slovenske farmacije = pharmaceutical journal of Slovenia. - ISSN 0014-8229 (Letn. 55, št. 1, mar. 2004, str. 5-10)Type of material - article, component partPublish date - 2004Language - slovenianCOBISS.SI-ID - 1475697
Author
Kočevar Nared, Jasna |
Ferlan, Andrej |
Krbavčič, Aleš |
Cvelbar, Martina
Topics
kontrola kvalitete |
kvaliteta |
zdravila |
laboratoriji
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source: Farmacevtski vestnik : strokovno glasilo slovenske farmacije = pharmaceutical journal of Slovenia. - ISSN 0014-8229 (Letn. 55, št. 1, mar. 2004, str. 5-10)
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Database name | Field | Year |
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Links to authors' personal bibliographies | Links to information on researchers in the SICRIS system |
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Kočevar Nared, Jasna | 13529 |
Ferlan, Andrej | ![]() |
Krbavčič, Aleš | 00839 |
Cvelbar, Martina | 14936 |
Source: Personal bibliographies
and: SICRIS
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