2293 KB35 KB200520252022Cukjati, MarkoŠvajger, UrbanŠvajger, Urbanštevilka:2letnik:73str. 79-88ISSN:0014-8229COBISSID_HOST:107885571URN:URN:NBN:SI:doc-FWDN74Z3slSlovensko farmacevtsko društvoFarmacevtski vestnikadvanced therapy medi- cinal productscelična terapijacell therapygene therapygenska terapijazdravila za napredna zdravljenjaZdravila za napredno zdravljenje| Advanced therapy medicinal products| naslednja generacija zdravil| next generation of medicines|Advanced therapy medicinal products (ATMPs) comprise medicinal products based on cells, genes and tissue-engineered products that are rapidly gaining in importance in contemporary pharmaceutical and medical professions. While ATMPs have been a subject of focused and extensive basic and preclinical research within the most advanced research institutes worldwide in the last decades, in recent years, we are witnessing an increase in number of ATMPs that have gained marketing authorization both in the United States, as well as in member states of the EU. In development, manufacture, clinical translation and last but not least, regulation of ATMPs, the pharmaceutical profession is confronting numerous new challenges, which reflect several special features of this new generation of drugs. At the same time ATMPs are accompanied by a promising fact, that they represent a potential for the treatment of some of the most severe, previously incurable diseases, and a therapeutic approach that may significantly enhance patient's quality of life in the futureZdravila za napredno zdravljenje (ZNZ) obsegajo zdravila na osnovi celic, genov in tkivno inženirskih izdelkov, ki v sodobni farmacevtski in medicinski stroki pospešeno pridobivajo na pomembnosti. Medtem ko so bila v zadnjih desetletjih ZNZ predmet intenzivnih bazičnih in predkliničnih raziskav v najnaprednejših raziskovalnih centrih po svetu, smo v zadnjih letih priča porastu števila tistih, ki so tako v ZDA kot državah članicah Evropske unije pridobila dovoljenje za promet. Pri razvoju, proizvodnji, klinični translaciji in nenazadnje v regulativi ZNZ se farmacevtska stroka srečuje s številnimi novostmi, ki so odsev mnogih posebnosti te naslednje generacije zdravil. Obenem pa vse skupaj spremlja obetavno dejstvo, da predstavljajo ZNZ potencial za zdravljenje nekaterih najhujših, pred tem neozdravljivih bolezni ter terapevtski pristop, ki bo lahko v prihodnosti značilno povečal kakovost življenja pacientov s kroničnimi boleznimiTEXTznanstveno časopisjejournalsSlovenian National E-content AggregatorNational and University Library of SloveniaSlovensko farmacevtsko društvo