Integrisani biofarmaceutski pristup u razvoju i karakterizaciji lekova: opšti koncept i primena
| Autor: | R Svetlana Ibric, V Jelena Parojcic, V Sandra Cvijic |
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| Rok vydání: | 2020 |
| Předmět: |
Drug
Biowaiver Computer science General Chemical Engineering media_common.quotation_subject in vitro-in vivokorelacija 02 engineering and technology lcsh:Chemical technology 030226 pharmacology & pharmacy fiziolo-ški zasnovani farmakokinetički/biofarma-ceutski modeli 03 medical and health sciences In vitro-in vivo correlation 0302 clinical medicine in vitro-in vivo correlation dissolution testing Physiologically based pharmacokinetic/biopharmaceutics modeling Dissolution testing lcsh:TP1-1185 izostavljanje in vivo stu-dija media_common Pharmaceutical industry business.industry Management science Biopharmaceutics physiologically based pharmacokinetic/biopharmaceutics modeling General Chemistry 021001 nanoscience & nanotechnology Biopharmaceutics Classification System biowaiver Clinical performance 3. Good health clinical performance klinički učinak Biopharmaceutical Drug development ispitivanje brzine ras-tvaranja Drug delivery 0210 nano-technology business |
| Zdroj: | Hemijska industrija Hemijska Industrija, Vol 74, Iss 6, Pp 389-397 (2020) |
| Popis: | The 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. Značaj 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. |
| Databáze: | OpenAIRE |
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