20.500.12556/DKUM-21547 Registracija medicinskih plinov kot zdravil na primeru medicinskega kisika Times New Roman CE; Registration of medical gases as medicines on example of medical oxygen. Medicinski plini, ki se uporabljajo v humani medicini, so zdravila, za katera je potrebno pridobiti dovoljenje za promet v skladu s Pravilnikom o dovoljenju za promet z zdravilom. Zakonodaja s področja zdravil pa predpisuje, da je potrebno pridobiti ustrezna dovoljenja za dejavnosti izdelave ter prometa z zdravilom. Vsa zdravila, ki so v prometu v Republiki Sloveniji, morajo biti po zakonodaji izdelana in kontrolirana v skladu s smernicami Evropske farmakopeje, katera vsebuje predpise za izdelavo zdravil, ugotavljanje njihove čistote, istovetnosti ter preskušanje parametrov zdravil in snovi, iz katerih so le-ta izdelana. Opisali smo, kako pomembni so postopki za preskušanje zdravil, saj z njimi zagotovimo varnost in učinkovitost zdravila. Tako smo v eksperimentalnem delu, ki je potekal v laboratoriju podjetja Messer Slovenija, d.o.o., opisali analizne metode za medicinski kisik, s katerimi določamo identiteto, vsebnost in nečistoče, ki so določene po Evropski farmakopeji. Rezultati so potrdili, da so vsi parametri izpolnili predpisane zahteve in da je proces stabilen in obnovljiv. Medical gases used in human medicine are drugs that need permission for distribution in accordance with the Rules for distribution of medicines. The legislation for medicines says that for production and distribution all the necessary permissions must be obtained. All medicines marketed in the Republic of Slovenia must be according to the law, designed and controlled in accordance with the guidelines of the European Pharmacopoeia, which contains provisions for the manufacture of medicines, methods for determination of their purity, identity, and testing parameters of drugs and substances of which medicines are made. We described how important are the procedures for testing of chemicals, as these ensure the safety and efficacy of the drug. In our experimental work, which was conducted in the laboratory of Messer Slovenia d.o.o., we described the analytical methods used to determine identity and content of impurities, which are set by the European Pharmacopoeia. The results confirmed that all the parameters meet legal requirements and that the process is stable and renewable. medicinski kisik postopek registracije zdravila zahteve Evropske farmakopeje analizne metode. UDK: 615.2(043.2) medical oxygen drug registration procedure requirements of the European Pharmacopoeia analytical methods. UDK: 615.2(043.2) true true false [B. Lisjak] Slovenski jezik Angleški jezik Diplomsko delo 2011-12-04 19:09:17 2011-12-06 07:55:04 2022-04-14 10:40:57 2023-12-28 03:09:08 2011 0 Maribor 0 0000-00-00 NiDoloceno NiDoloceno NiDoloceno 0000-00-00 0000-00-00 0000-00-00 615.2(043.2) 16039958 URN:SI:UM:DK:GSEXVD6C VS_Lisjak_Barbara_2011.pdf VS_Lisjak_Barbara_2011.pdf 1 77DE7EE56BE2DEBEB6A31051432580D3 28cbc71dccf2af63ef11ad9cdfdce0775198dc40171b4409d44e9cb6a2d6739f e2cc0e0d-7c05-11eb-bb7a-00155d0001ca 20.500.12556/dkum/1297113a-b182-4307-9686-aeafee1a60e6 https://dk.um.si/Dokument.php?lang=slv&id=27347 Fakulteta za kemijo in kemijsko tehnologijo 0 0 0