TY  - JOUR
AU  - Stević, Ivana
AU  - Janković, Slobodan M.
AU  - Milošević-Georgiev, Andrijana
AU  - Marinković, Valentina
AU  - Lakić, Dragana
PY  - 2024
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/5618
AB  - Serious hematological adverse drug reactions (HADRs) may lead to or prolong hospitalization
and even cause death. The aim of this study was to determine the regulatory factors associated
with HADRs caused by drugs that were authorized up to July 2023 by the European Medicines
Agency (EMA) and to evaluate the frequency of HADRs. Using a cross-sectional approach, the type
and frequency of HADRs were collected from the Summaries of Product Characteristics of Drugs
Authorized by the EMA and analyzed within proprietary, nonproprietary, and biosimilar/biological
frameworks. Multivariate statistical analysis was used to investigate the associations of generic
status, biosimilar status, conditional approval, exceptional circumstances, accelerated assessment,
orphan drug status, years on the market, administration route, and inclusion on the Essential
Medicines List (EML) with HADRs. In total, 54.78% of proprietary drugs were associated with HADRs
at any frequency, while anemia, leucopenia, and thrombocytopenia were observed in approximately
36% of the patients. The predictors of any HADR, anemia, and thrombocytopenia of any frequency
are generic status, biosimilar status, and inclusion on the EML, while the only protective factor is the
administration route. Biosimilars and their originator biologicals have similar frequencies of HADRs;
the only exception is somatropin. Knowledge of the regulatory factors associated with HADRs could
help clinicians address monitoring issues when new drugs are introduced for the treatment of patients.
PB  - Nature Portfolio
T2  - Scientific Reports
T1  - Factors associated with hematological adverse reactions of drugs authorized via the centralized procedure
VL  - 14
IS  - 1
SP  - 9074
DO  - 10.1038/s41598-024-59710-3
ER  - 

@article{
author = "Stević, Ivana and Janković, Slobodan M. and Milošević-Georgiev, Andrijana and Marinković, Valentina and Lakić, Dragana",
year = "2024",
abstract = "Serious hematological adverse drug reactions (HADRs) may lead to or prolong hospitalization
and even cause death. The aim of this study was to determine the regulatory factors associated
with HADRs caused by drugs that were authorized up to July 2023 by the European Medicines
Agency (EMA) and to evaluate the frequency of HADRs. Using a cross-sectional approach, the type
and frequency of HADRs were collected from the Summaries of Product Characteristics of Drugs
Authorized by the EMA and analyzed within proprietary, nonproprietary, and biosimilar/biological
frameworks. Multivariate statistical analysis was used to investigate the associations of generic
status, biosimilar status, conditional approval, exceptional circumstances, accelerated assessment,
orphan drug status, years on the market, administration route, and inclusion on the Essential
Medicines List (EML) with HADRs. In total, 54.78% of proprietary drugs were associated with HADRs
at any frequency, while anemia, leucopenia, and thrombocytopenia were observed in approximately
36% of the patients. The predictors of any HADR, anemia, and thrombocytopenia of any frequency
are generic status, biosimilar status, and inclusion on the EML, while the only protective factor is the
administration route. Biosimilars and their originator biologicals have similar frequencies of HADRs;
the only exception is somatropin. Knowledge of the regulatory factors associated with HADRs could
help clinicians address monitoring issues when new drugs are introduced for the treatment of patients.",
publisher = "Nature Portfolio",
journal = "Scientific Reports",
title = "Factors associated with hematological adverse reactions of drugs authorized via the centralized procedure",
volume = "14",
number = "1",
pages = "9074",
doi = "10.1038/s41598-024-59710-3"
}

Stević, I., Janković, S. M., Milošević-Georgiev, A., Marinković, V.,& Lakić, D.. (2024). Factors associated with hematological adverse reactions of drugs authorized via the centralized procedure. in Scientific Reports
Nature Portfolio., 14(1), 9074.
https://doi.org/10.1038/s41598-024-59710-3

Stević I, Janković SM, Milošević-Georgiev A, Marinković V, Lakić D. Factors associated with hematological adverse reactions of drugs authorized via the centralized procedure. in Scientific Reports. 2024;14(1):9074.
doi:10.1038/s41598-024-59710-3 .

Stević, Ivana, Janković, Slobodan M., Milošević-Georgiev, Andrijana, Marinković, Valentina, Lakić, Dragana, "Factors associated with hematological adverse reactions of drugs authorized via the centralized procedure" in Scientific Reports, 14, no. 1 (2024):9074,
https://doi.org/10.1038/s41598-024-59710-3 . .

TY  - JOUR
AU  - Janković, Slobodan
AU  - Bogavac-Stanojević, Nataša
AU  - Mikulić, Iva
AU  - Izetbegović, Sebija
AU  - Iličković, Ivana
AU  - Krajnović, Dušanka
AU  - Suljic Mehmedika, Enra
AU  - Gojak, Refet
AU  - Mehičević, Admir
AU  - Gazibera, Belma
AU  - Mahmutbegović, Nevena
AU  - Stojadinović, Milorad
AU  - Janković, Nikola
AU  - Miljković, Sanja
AU  - Popović, Slađana
AU  - Blidarević, Bojan
AU  - Mugoša, Snežana
AU  - Đorđević, Zorana
PY  - 2021
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/3994
AB  - Prenos instrumentov za merjenje kakovosti življenja, razvitih v nekaterih, večinoma razvitejših delih sveta, zahteva transkulturno validacijo. Kljub temu tovrstni instrumenti običajno ne zajemajo regionalno specifičnih vidikov kakovosti življenja, povezanih z zdravjem. Namen študije je bil razviti in potrditi zanesljiv vprašalnik v srbskem, hrvaškem, bosansko-hrvaško-srbskem in črnogorskem jeziku, primeren za merjenje kakovosti življenja, povezanega z zdravjem odraslih.
AB  - Translations of instruments for measuring quality of life developed in certain, mostly more
developed, parts of the world usually do not cover regionally specific aspects of health-related quality of life,
even after transcultural validation. The aim of this study was to develop and validate a reliable questionnaire
in Serbian, Croatian, Bosnian, and Montenegrin languages suitable for measuring health-related quality of life
in adults.
PB  - Sciendo
T2  - Zdravstveno varstvo
T1  - Vprašalnik za merjenje kakovosti življenja, povezanega z zdravjem
T1  - A questionnaire for rating health-related quality of life
VL  - 60
IS  - 4
SP  - 260
EP  - 268
DO  - 10.2478/sjph-2021-0035
ER  - 

@article{
author = "Janković, Slobodan and Bogavac-Stanojević, Nataša and Mikulić, Iva and Izetbegović, Sebija and Iličković, Ivana and Krajnović, Dušanka and Suljic Mehmedika, Enra and Gojak, Refet and Mehičević, Admir and Gazibera, Belma and Mahmutbegović, Nevena and Stojadinović, Milorad and Janković, Nikola and Miljković, Sanja and Popović, Slađana and Blidarević, Bojan and Mugoša, Snežana and Đorđević, Zorana",
year = "2021",
abstract = "Prenos instrumentov za merjenje kakovosti življenja, razvitih v nekaterih, večinoma razvitejših delih sveta, zahteva transkulturno validacijo. Kljub temu tovrstni instrumenti običajno ne zajemajo regionalno specifičnih vidikov kakovosti življenja, povezanih z zdravjem. Namen študije je bil razviti in potrditi zanesljiv vprašalnik v srbskem, hrvaškem, bosansko-hrvaško-srbskem in črnogorskem jeziku, primeren za merjenje kakovosti življenja, povezanega z zdravjem odraslih., Translations of instruments for measuring quality of life developed in certain, mostly more
developed, parts of the world usually do not cover regionally specific aspects of health-related quality of life,
even after transcultural validation. The aim of this study was to develop and validate a reliable questionnaire
in Serbian, Croatian, Bosnian, and Montenegrin languages suitable for measuring health-related quality of life
in adults.",
publisher = "Sciendo",
journal = "Zdravstveno varstvo",
title = "Vprašalnik za merjenje kakovosti življenja, povezanega z zdravjem, A questionnaire for rating health-related quality of life",
volume = "60",
number = "4",
pages = "260-268",
doi = "10.2478/sjph-2021-0035"
}

Janković, S., Bogavac-Stanojević, N., Mikulić, I., Izetbegović, S., Iličković, I., Krajnović, D., Suljic Mehmedika, E., Gojak, R., Mehičević, A., Gazibera, B., Mahmutbegović, N., Stojadinović, M., Janković, N., Miljković, S., Popović, S., Blidarević, B., Mugoša, S.,& Đorđević, Z.. (2021). Vprašalnik za merjenje kakovosti življenja, povezanega z zdravjem. in Zdravstveno varstvo
Sciendo., 60(4), 260-268.
https://doi.org/10.2478/sjph-2021-0035

Janković S, Bogavac-Stanojević N, Mikulić I, Izetbegović S, Iličković I, Krajnović D, Suljic Mehmedika E, Gojak R, Mehičević A, Gazibera B, Mahmutbegović N, Stojadinović M, Janković N, Miljković S, Popović S, Blidarević B, Mugoša S, Đorđević Z. Vprašalnik za merjenje kakovosti življenja, povezanega z zdravjem. in Zdravstveno varstvo. 2021;60(4):260-268.
doi:10.2478/sjph-2021-0035 .

Janković, Slobodan, Bogavac-Stanojević, Nataša, Mikulić, Iva, Izetbegović, Sebija, Iličković, Ivana, Krajnović, Dušanka, Suljic Mehmedika, Enra, Gojak, Refet, Mehičević, Admir, Gazibera, Belma, Mahmutbegović, Nevena, Stojadinović, Milorad, Janković, Nikola, Miljković, Sanja, Popović, Slađana, Blidarević, Bojan, Mugoša, Snežana, Đorđević, Zorana, "Vprašalnik za merjenje kakovosti življenja, povezanega z zdravjem" in Zdravstveno varstvo, 60, no. 4 (2021):260-268,
https://doi.org/10.2478/sjph-2021-0035 . .

TY  - JOUR
AU  - Stojanović, Stefan
AU  - Nićiforović, Jovan
AU  - Živanović, Sandra
AU  - Odović, Jadranka
AU  - Jelić, Ratomir
PY  - 2020
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/3614
AB  - bstract: Concomitant use of two or more drugs in therapy is becoming a more frequent phenomenon and clinically relevant drug–drug interactions at the level of binding to human serum albumin (HSA) are more often. The influence of fluoroquinolones–sparfloxacin, levofloxacin, and ciprofloxacin, on the interaction between tigecycline and HSA, was investigated in vitro by means of fluorescence and absorption spectroscopy. The results of UV–Vis and fluorescence spectroscopy showed that the fluorescence quenching of HSA was a result of the formation of new complexes through a static quenching process. The binding constants (Ka) and the number of binding sites (n) of all systems were calculated. The presence of sparfloxacin and ciprofloxacin increases and that of levofloxacin slightly decreases the binding constant of the HSA–tigecycline system. Competitive binding studies in the presence of site-specific markers showed that tigecycline was not significantly displaced by ibuprofen, but warfarin showed a significant displacement of tigecycline. These results suggest that the competitive binding of tigecycline and warfarin to HSA exists. The results confirm that the binding site of tigecycline is mainly located in Sudlow’s site I (subdomain IIA) of HSA. Graphic abstract: [Figure not available: see fulltext.
PB  - Springer
T2  - Monatshefte fur Chemie
T1  - Spectroscopic studies on the drug–drug interaction: the influence of fluoroquinolones on the affinity of tigecycline to human serum albumin and identification of the binding site
VL  - 151
SP  - 999
EP  - 1007
DO  - 10.1007/s00706-020-02627-0
ER  - 

@article{
author = "Stojanović, Stefan and Nićiforović, Jovan and Živanović, Sandra and Odović, Jadranka and Jelić, Ratomir",
year = "2020",
abstract = "bstract: Concomitant use of two or more drugs in therapy is becoming a more frequent phenomenon and clinically relevant drug–drug interactions at the level of binding to human serum albumin (HSA) are more often. The influence of fluoroquinolones–sparfloxacin, levofloxacin, and ciprofloxacin, on the interaction between tigecycline and HSA, was investigated in vitro by means of fluorescence and absorption spectroscopy. The results of UV–Vis and fluorescence spectroscopy showed that the fluorescence quenching of HSA was a result of the formation of new complexes through a static quenching process. The binding constants (Ka) and the number of binding sites (n) of all systems were calculated. The presence of sparfloxacin and ciprofloxacin increases and that of levofloxacin slightly decreases the binding constant of the HSA–tigecycline system. Competitive binding studies in the presence of site-specific markers showed that tigecycline was not significantly displaced by ibuprofen, but warfarin showed a significant displacement of tigecycline. These results suggest that the competitive binding of tigecycline and warfarin to HSA exists. The results confirm that the binding site of tigecycline is mainly located in Sudlow’s site I (subdomain IIA) of HSA. Graphic abstract: [Figure not available: see fulltext.",
publisher = "Springer",
journal = "Monatshefte fur Chemie",
title = "Spectroscopic studies on the drug–drug interaction: the influence of fluoroquinolones on the affinity of tigecycline to human serum albumin and identification of the binding site",
volume = "151",
pages = "999-1007",
doi = "10.1007/s00706-020-02627-0"
}

Stojanović, S., Nićiforović, J., Živanović, S., Odović, J.,& Jelić, R.. (2020). Spectroscopic studies on the drug–drug interaction: the influence of fluoroquinolones on the affinity of tigecycline to human serum albumin and identification of the binding site. in Monatshefte fur Chemie
Springer., 151, 999-1007.
https://doi.org/10.1007/s00706-020-02627-0

Stojanović S, Nićiforović J, Živanović S, Odović J, Jelić R. Spectroscopic studies on the drug–drug interaction: the influence of fluoroquinolones on the affinity of tigecycline to human serum albumin and identification of the binding site. in Monatshefte fur Chemie. 2020;151:999-1007.
doi:10.1007/s00706-020-02627-0 .

Stojanović, Stefan, Nićiforović, Jovan, Živanović, Sandra, Odović, Jadranka, Jelić, Ratomir, "Spectroscopic studies on the drug–drug interaction: the influence of fluoroquinolones on the affinity of tigecycline to human serum albumin and identification of the binding site" in Monatshefte fur Chemie, 151 (2020):999-1007,
https://doi.org/10.1007/s00706-020-02627-0 . .