TY  - JOUR
AU  - Stević, Ivana
AU  - Petrović, Nemanja
AU  - Janković, Slobodan
PY  - 2023
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/5266
AB  - To satisfy the needs of pediatric and other patients with focal onset seizures who cannot swallow solid dosage forms of zonisamide, an oral liquid form of this drug is necessary in clinical practice. Although there are two oral suspensions of zonisamide with marketing authorization (MA), there are issues of availability and high cost which limit their use and inspire extemporaneous compounding. Extemporaneously compounded oral suspensions of zonisamide are prepared according to different formulas and vary in stability; therefore it is essential to test this characteristic. Bioequivalence of extemporaneously compounded oral suspensions has never been tested, and the efficacy and safety of zonisamide oral suspensions have generally not been demonstrated in clinical trials. As a narrow therapeutic window drug, zonisamide requires precision in dosing, which could be achieved only with dosage forms with established bioavailability, efficacy, and safety. In order to avoid underdosing and toxicity with zonisamide oral suspensions and utilize their full therapeutic potential, it is necessary to perform bioequivalence studies with each variation of extemporaneously compounded oral suspension and also clinical trials with both commercial and extemporaneous oral suspensions of zonisamide.
PB  - Dove Medical Press Ltd
T2  - Patient Preference and Adherence
T1  - Bioequivalence of Different Formulations of Zonisamide Oral Suspensions: A Short Review
VL  - 17
SP  - 2841
EP  - 2845
DO  - 10.2147/PPA.S383038
ER  - 

@article{
author = "Stević, Ivana and Petrović, Nemanja and Janković, Slobodan",
year = "2023",
abstract = "To satisfy the needs of pediatric and other patients with focal onset seizures who cannot swallow solid dosage forms of zonisamide, an oral liquid form of this drug is necessary in clinical practice. Although there are two oral suspensions of zonisamide with marketing authorization (MA), there are issues of availability and high cost which limit their use and inspire extemporaneous compounding. Extemporaneously compounded oral suspensions of zonisamide are prepared according to different formulas and vary in stability; therefore it is essential to test this characteristic. Bioequivalence of extemporaneously compounded oral suspensions has never been tested, and the efficacy and safety of zonisamide oral suspensions have generally not been demonstrated in clinical trials. As a narrow therapeutic window drug, zonisamide requires precision in dosing, which could be achieved only with dosage forms with established bioavailability, efficacy, and safety. In order to avoid underdosing and toxicity with zonisamide oral suspensions and utilize their full therapeutic potential, it is necessary to perform bioequivalence studies with each variation of extemporaneously compounded oral suspension and also clinical trials with both commercial and extemporaneous oral suspensions of zonisamide.",
publisher = "Dove Medical Press Ltd",
journal = "Patient Preference and Adherence",
title = "Bioequivalence of Different Formulations of Zonisamide Oral Suspensions: A Short Review",
volume = "17",
pages = "2841-2845",
doi = "10.2147/PPA.S383038"
}

Stević, I., Petrović, N.,& Janković, S.. (2023). Bioequivalence of Different Formulations of Zonisamide Oral Suspensions: A Short Review. in Patient Preference and Adherence
Dove Medical Press Ltd., 17, 2841-2845.
https://doi.org/10.2147/PPA.S383038

Stević I, Petrović N, Janković S. Bioequivalence of Different Formulations of Zonisamide Oral Suspensions: A Short Review. in Patient Preference and Adherence. 2023;17:2841-2845.
doi:10.2147/PPA.S383038 .

Stević, Ivana, Petrović, Nemanja, Janković, Slobodan, "Bioequivalence of Different Formulations of Zonisamide Oral Suspensions: A Short Review" in Patient Preference and Adherence, 17 (2023):2841-2845,
https://doi.org/10.2147/PPA.S383038 . .

TY  - GEN
AU  - Stević, Ivana
AU  - Janković, Slobodan M
AU  - Petrović, Nemanja
AU  - Čanak-Baltić, Nataša
AU  - Lakić, Dragana
PY  - 2022
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/5623
AB  - Drug-induced disorder „can result from unanticipated or anticipated drug effects“ (1).
The prevalence of hematological adverse drug reactions (ADR) in chemotherapeutics is
expected to be high; for non-chemotherapeutics, there is insufficient epidemiological data,
although a spontaneous reporting system is mandatory in a drug's life cycle (2-6). ADR is
considered to be the fifth cause of death, with the hospitalization rate caused by ADR estimated
to be between 0.9-7.9% (7-8), while one study suggests that about „10 to 20% of hospitalized
patients will experience ADRs during their stay“ (9). Frequency data on hospital admissions
due to hematological ADR vary between studies, e.g., 9% (7) up to 26.5% (10).
The study by Abu et al. categorized major ADR types based on system disorders, where
hematologic ADR encountered 9.9-15.2% of ADRs (9). The same study estimated costs per
ADR from 65.00 to 12,129.90 USD, whereas costs were generally lower when the micro-
costing approach was used (9).
A cost-of-illness (COI) study should be performed to precisely determine the costs
generated by ADR. COI studies measure the economic burden of an illness on society, health
insurance funds, or patients. Jefferson et al. (2000) defined “the aim of COI studies is
descriptive: to itemize, value, and sum the costs of a particular problem with the aim of giving
an idea of its economic burden“ (11). There are different methods of conducting this type of
study, such as prevalence‐based, incidence‐based, or econometric approaches, with again
different approaches (e.g., prospective, retrospective; top-down, bottom-up…) or with different
perspectives of COI studies (such as societal, health care system, third-party payer) (11).
However, micro-costing studies represent the gold standard for conducting COI studies (12).
Only a few cost drivers of HADR have been proven to date, e.g., prolonged in-hospital stay,
costs of using drugs, and transfusion costs (13-14).
T1  - Non-oncological
drug-induced blood disorders: a cost of illness study using the
microcosting Methodology - study plan [protocol]
UR  - https://hdl.handle.net/21.15107/rcub_farfar_5623
ER  - 

@misc{
author = "Stević, Ivana and Janković, Slobodan M and Petrović, Nemanja and Čanak-Baltić, Nataša and Lakić, Dragana",
year = "2022",
abstract = "Drug-induced disorder „can result from unanticipated or anticipated drug effects“ (1).
The prevalence of hematological adverse drug reactions (ADR) in chemotherapeutics is
expected to be high; for non-chemotherapeutics, there is insufficient epidemiological data,
although a spontaneous reporting system is mandatory in a drug's life cycle (2-6). ADR is
considered to be the fifth cause of death, with the hospitalization rate caused by ADR estimated
to be between 0.9-7.9% (7-8), while one study suggests that about „10 to 20% of hospitalized
patients will experience ADRs during their stay“ (9). Frequency data on hospital admissions
due to hematological ADR vary between studies, e.g., 9% (7) up to 26.5% (10).
The study by Abu et al. categorized major ADR types based on system disorders, where
hematologic ADR encountered 9.9-15.2% of ADRs (9). The same study estimated costs per
ADR from 65.00 to 12,129.90 USD, whereas costs were generally lower when the micro-
costing approach was used (9).
A cost-of-illness (COI) study should be performed to precisely determine the costs
generated by ADR. COI studies measure the economic burden of an illness on society, health
insurance funds, or patients. Jefferson et al. (2000) defined “the aim of COI studies is
descriptive: to itemize, value, and sum the costs of a particular problem with the aim of giving
an idea of its economic burden“ (11). There are different methods of conducting this type of
study, such as prevalence‐based, incidence‐based, or econometric approaches, with again
different approaches (e.g., prospective, retrospective; top-down, bottom-up…) or with different
perspectives of COI studies (such as societal, health care system, third-party payer) (11).
However, micro-costing studies represent the gold standard for conducting COI studies (12).
Only a few cost drivers of HADR have been proven to date, e.g., prolonged in-hospital stay,
costs of using drugs, and transfusion costs (13-14).",
title = "Non-oncological
drug-induced blood disorders: a cost of illness study using the
microcosting Methodology - study plan [protocol]",
url = "https://hdl.handle.net/21.15107/rcub_farfar_5623"
}

Stević, I., Janković, S. M., Petrović, N., Čanak-Baltić, N.,& Lakić, D.. (2022). Non-oncological
drug-induced blood disorders: a cost of illness study using the
microcosting Methodology - study plan [protocol]. .
https://hdl.handle.net/21.15107/rcub_farfar_5623

Stević I, Janković SM, Petrović N, Čanak-Baltić N, Lakić D. Non-oncological
drug-induced blood disorders: a cost of illness study using the
microcosting Methodology - study plan [protocol]. 2022;.
https://hdl.handle.net/21.15107/rcub_farfar_5623 .

Stević, Ivana, Janković, Slobodan M, Petrović, Nemanja, Čanak-Baltić, Nataša, Lakić, Dragana, "Non-oncological
drug-induced blood disorders: a cost of illness study using the
microcosting Methodology - study plan [protocol]" (2022),
https://hdl.handle.net/21.15107/rcub_farfar_5623 .