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Integrisani biofarmaceutski pristup u razvoju i karakterizaciji lekova: opšti koncept i primena

dc.creatorCvijić, Sandra
dc.creatorIbrić, Svetlana
dc.creatorParojčić, Jelena
dc.date.accessioned2021-03-03T12:28:39Z
dc.date.available2021-03-03T12:28:39Z
dc.date.issued2020
dc.identifier.issn0367-598X
dc.identifier.urihttps://farfar.pharmacy.bg.ac.rs/handle/123456789/3790
dc.description.abstractThe importance of biopharmaceutical considerations in pharmaceutical development and drug characterization has been well recognized both by pharmaceutical industry and regulatory authorities as a tool to establish predictive relationships between drug product quality attributes (in vitro data) and its clinical performance (in vivo data). In the present paper, contemporary biopharmaceutics toolkit including in vivo predictive dissolution testing, Biopharmaceutics Classification System, physiologically based pharmacokinetic and biopharmaceutics modeling and simulation, in vitro-in vivo correlation and biowaiver, are reviewed with regards to relevant general principles and applicability. The recently introduced innovative strategy for patient-centric drug development using an integrated systems approach grounded in fundamental biopharmaceutics concepts, clinical insights and therapeutic drug delivery targets, described as Biopharmaceutics Risk Assessment Roadmap (BioRAM) is also presented. Further development in the field will benefit from joint efforts and exchange of knowledge and experiences between pharmaceutical industry and regulatory authorities for the common goal to accelerate development of effective and safe drug products designed in accordance with patients’ needs and expectations.
dc.description.abstractZnačaj biofarmaceutskih razmatranja u razvoju i karakterizaciji lekova s ciljem uspostavljanja korelacije i mogućnosti predviđanja odnosa između in vitropodataka, odnosno karakteristika kvaliteta leka i njegovog in vivoponašanja/kliničkog učinka, prepoznata je kako od strane farmaceutske industrije, tako i od strane odgovarajućih regulatornih tela. U radu je dat pregled savremenih biofarmaceutskih alata,uključujući prediktivno ispitivanje brzine rastvaranja lekovite supstance iz farmaceutskog oblika leka, Biofarmaceutski sistem klasifikacije, fiziološki zasnovano farmakokinetičko i biofarmaceutsko modelovanje i simulacije, in vitro-in vivokorelaciju i mogućnost izostavljanja in vivostudija bioekvivalencije (engl. biowaiver) iz aspekta opštih principa i mogućnosti primene u razvoju i karakterizaciji lekova.Predstavljena je i nedavno osmišljena inovativna strategija za razvoj leka usmerena ka pacijentu, uz primenu integrisanog sistemskog pristupa zasnovanog na osnovnim biofarmaceutskim konceptima, uvidu u kliničku situaciju i definisanim terapijskim ciljevima označena kao Plan aktivnosti za procenu biofarmaceutskog rizika (engl. Biopharmaceutics Risk Assessment Roadmap, BioRAM). Očekuje se da će daljem razvoju u ovoj oblasti najviše doprineti združene aktivnosti i razmena znanja i iskustava između farmaceutskih kompanija i regulatornih agencija sa zajedničkim ciljem da se ubrza razvoj efikasnih i bezbednihlekova dizajniranih u skladu sa potrebama i očekivanjima pacijenata.
dc.publisherAssociation of Chemists and Chemical Engineers of Serbia
dc.rightsopenAccess
dc.rights.urihttps://creativecommons.org/licenses/by-nc-nd/4.0/
dc.sourceHemijska Industrija
dc.subjectBiowaiver
dc.subjectClinical performance
dc.subjectDissolution testing
dc.subjectIn vitro-in vivo correlation
dc.subjectPhysiologically based pharmacokinetic/biopharmaceutics modeling
dc.subjectizostavljanje in vivo stu-dija
dc.subjectklinički učinak
dc.subjectispitivanje brzine ras-tvaranja
dc.subjectin vitro-in vivokorelacija
dc.subjectfiziolo-ški zasnovani farmakokinetički/biofarma-ceutski modeli
dc.titleIntegrated biopharmaceutical approach in pharmaceutical development and drug characterization: General concept and application
dc.titleIntegrisani biofarmaceutski pristup u razvoju i karakterizaciji lekova: opšti koncept i primena
dc.typearticle
dc.rights.licenseBY-NC-ND
dcterms.abstractЦвијић, Сандра; Ибрић, Светлана; Паројчић, Јелена; Интегрисани биофармацеутски приступ у развоју и карактеризацији лекова: општи концепт и примена; Интегратед биопхармацеутицал аппроацх ин пхармацеутицал девелопмент анд друг цхарацтеризатион: Генерал цонцепт анд апплицатион;
dc.citation.volume74
dc.citation.issue6
dc.citation.spage389
dc.citation.epage397
dc.citation.rankM23
dc.identifier.wos000613646400004
dc.identifier.doi10.2298/HEMIND210104002C
dc.identifier.scopus2-s2.0-85101154126
dc.identifier.fulltexthttp://farfar.pharmacy.bg.ac.rs/bitstream/id/8619/Integrated_biopharmaceutica_approach_pub_2020.pdf
dc.type.versionpublishedVersion


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