Generički peptidni lijekovi: metode karakterizacije i procjena istovjetnosti

Bernatović, Katarina

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master's thesis

Generički peptidni lijekovi: metode karakterizacije i procjena istovjetnosti

Zagreb: University of Zagreb, Faculty of Pharmacy and Biochemistry, 2020. urn:nbn:hr:163:834646

Bernatović, Katarina

University of Zagreb
Faculty of Pharmacy and Biochemistry

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APA 6th Edition

Bernatović, K. (2020). Generički peptidni lijekovi: metode karakterizacije i procjena istovjetnosti (Master's thesis). Zagreb: University of Zagreb, Faculty of Pharmacy and Biochemistry. Retrieved from https://urn.nsk.hr/urn:nbn:hr:163:834646

MLA 8th Edition

Bernatović, Katarina. "Generički peptidni lijekovi: metode karakterizacije i procjena istovjetnosti." Master's thesis, University of Zagreb, Faculty of Pharmacy and Biochemistry, 2020. https://urn.nsk.hr/urn:nbn:hr:163:834646

Chicago 17th Edition

Harvard

Bernatović, K. (2020). 'Generički peptidni lijekovi: metode karakterizacije i procjena istovjetnosti', Master's thesis, University of Zagreb, Faculty of Pharmacy and Biochemistry, accessed 25 November 2024, https://urn.nsk.hr/urn:nbn:hr:163:834646

Vancouver

Bernatović K. Generički peptidni lijekovi: metode karakterizacije i procjena istovjetnosti [Master's thesis]. Zagreb: University of Zagreb, Faculty of Pharmacy and Biochemistry; 2020 [cited 2024 November 25] Available at: https://urn.nsk.hr/urn:nbn:hr:163:834646

IEEE

K. Bernatović, "Generički peptidni lijekovi: metode karakterizacije i procjena istovjetnosti", Master's thesis, University of Zagreb, Faculty of Pharmacy and Biochemistry, Zagreb, 2020. Available at: https://urn.nsk.hr/urn:nbn:hr:163:834646

Cite this item: https://urn.nsk.hr/urn:nbn:hr:163:834646

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Metadata

Title	Generički peptidni lijekovi: metode karakterizacije i procjena istovjetnosti
Title (english)	Generic peptide drugs: characterization methods and sameness evaluation
Author	Katarina Bernatović
Mentor	Biserka Cetina Čižmek (mentor)
Committee member	Biserka Cetina Čižmek (predsjednik povjerenstva)
Committee member	Jelena Filipović-Grčić (član povjerenstva)
Committee member	Anita Hafner (član povjerenstva)
Granter	University of Zagreb Faculty of Pharmacy and Biochemistry Zagreb
Defense date and country	2020-09-11, Croatia
Scientific / art field, discipline and subdiscipline	BIOMEDICINE AND HEALTHCARE Pharmacy Pharmacy
Abstract	Peptidni lijekovi i njihov široki terapijski potencijal postali su dostupniji općoj populaciji dolaskom generičkih peptidnih lijekova na tržište. Usprkos tome što ne postoje opće harmonizirane zakonske smjernice za proizvodnju i kontrolu kvalitete peptida, farmaceutska industrija pod pritiskom je plasiranja generičkih peptidnih lijekova na tržište kako bi se zadovoljile potrebe liječenja populacije. Kako bi generički lijek dobio odobrenje za stavljanje na tržište, potrebno je dokazati njegovu istovjetnost s originalnim lijekom, često proizvedenim različitim proizvodnim procesom. U svrhu ispitivanja istovjetnosti generičkih i originalnih peptidnih lijekova provode se brojne usporedne analize korištenjem širokog spektra analitičkih tehnika. Potrebno je provesti identifikaciju tvari, analizirati različite razine strukturnog uređenja peptidnih molekula, ispitati njihova fizikalno-kemijska i biološka svojstva te utjecaj na organizam u smislu imunogenosti te biološke aktivnosti i potentnosti. Posebnu pažnju treba posvetiti ispitivanju prisutnih i mogućih onečišćenja u djelatnoj tvari te u završnoj formulaciji. U radu je prikazana karakterizacija dekapeptida ikatibanta upotrebom novijih osjetljivih analitičkih tehnika.
Abstract (english)	Peptide drugs and their wide therapeutic potential have become more available for patients around the world when generic peptide drugs entered to drug market. Although there are still no general guidelines for manufacturing and quality control of peptide drugs, pharmaceutical industry is working under pressure in order to place generic peptides to the market so they could accomplish their purpose in medical treatment. Pharmaceutical companies that are seeking approval for putting generic peptide drugs on the market need to demonstrate sameness between original and generic peptide drug. This is often challenging due to the fact that manufacturing processess of original and generic drug could be different. Wide range of analytical techniques are used in order to establish sameness and justify equivalence between original and generic peptide drugs. Some of many comparative tests that have to be done are identification of active pharmaceutical substance, molecule structure characterization, examination of physicochemical and biological properties such as biological activity and immunogenicity. Particular attention should be given to impurities that could be present in the active substance material or final formulation of the drug. In this Bachelor's Thesis, characterization of decapeptide icatibant using novel sensitive analytical techniques has also been presented.
Keywords
Keywords (english)
Language	croatian
URN:NBN	urn:nbn:hr:163:834646
Study programme	Title: Pharmacy Study programme type: university Study level: integrated undergraduate and graduate Academic / professional title: magistar/magistra farmacije (magistar/magistra farmacije)
Type of resource	Text
File origin	Born digital
Access conditions	Open access
Terms of use
Repository	Repository of Faculty of Pharmacy and Biochemistry University of Zagreb
Created on	2021-04-29 13:29:12