Concept and utility of population pharmacokinetic and pharmacokinetic/ pharmacodynamic models in drug development and clinical practice
Koncept i upotreba populacionih farmakokinetičkih i farmakokinetičko/farmakodinamičkih modela u razvoju leka i kliničkoj praksi
Аутори
Roganović, MašaHomšek, Ana
Jovanović, Marija
Topić-Vučenović, Valentina
Ćulafić, Milica
Miljković, Branislava
Vučićević, Katarina
Чланак у часопису (Објављена верзија)
Метаподаци
Приказ свих података о документуАпстракт
Due to frequent clinical trial failures and consequently fewer new drug approvals, the need
for improvement in drug development has, to a certain extent, been met using model-based drug
development. Pharmacometrics is a part of pharmacology that quantifies drug behaviour,
treatment response and disease progression based on different models (pharmacokinetic - PK,
pharmacodynamic - PD, PK/PD models, etc.) and simulations. Regulatory bodies (European
Medicines Agency, Food and Drug Administration) encourage the use of modelling and
simulations to facilitate decision-making throughout all drug development phases. Moreover, the
identification of factors that contribute to variability provides a basis for dose individualisation in
routine clinical practice. This review summarises current knowledge regarding the application of
pharmacometrics in drug development and clinical practice with emphasis on the population
modelling approach.
Usled čestih neuspeha u kliničkim ispitivanjima i posledično manjeg broja odobrenja novih lekova, potreba za poboljšanjem u razvoju lekova je u određenoj meri zadovoljena korišćenjem pristupa razvoja lekova zasnovanog na modelu. Farmakometrija predstavlja granu farmakologije koja kvantifikuje ponašanje leka, odgovor na terapiju i napredovanje bolesti na osnovu različitih modela (farmakokinetički - FK, farmakodinamički - FD, FK/FD modeli itd.) i simulacija. Regulatorna tela (Evropska agencija za lekove, Uprava za hranu i lekove) podstiču primenu modelovanja i simulacija u svrhu lakšeg donošenja odluka tokom svih faza razvoja lekova. Štaviše, identifikacija faktora koji doprinose varijabilnosti predstavlja osnovu za individualizaciju doze u rutinskoj kliničkoj praksi. Ovaj revijalni rad sumira trenutno znanje u vezi sa primenom farmakometrije u razvoju lekova i kliničkoj praksi sa fokusom na populacionu analizu.
Кључне речи:
Pharmacometrics / population analysis / pharmacokinetics / pharmacokinetic-pharmacodynamic modelling / farmakometrija / populaciona analiza / farmakokinetika / farmakokinetičko-farmakodinamičko modelovanjeИзвор:
Arhiv za farmaciju, 2021, 71, 4, 336-353Издавач:
- Beograd : Savez farmaceutskih udruženja Srbije
Финансирање / пројекти:
- Министарство науке, технолошког развоја и иновација Републике Србије, институционално финансирање - 200161 (Универзитет у Београду, Фармацеутски факултет) (RS-MESTD-inst-2020-200161)
Институција/група
PharmacyTY - JOUR AU - Roganović, Maša AU - Homšek, Ana AU - Jovanović, Marija AU - Topić-Vučenović, Valentina AU - Ćulafić, Milica AU - Miljković, Branislava AU - Vučićević, Katarina PY - 2021 UR - https://farfar.pharmacy.bg.ac.rs/handle/123456789/3960 AB - Due to frequent clinical trial failures and consequently fewer new drug approvals, the need for improvement in drug development has, to a certain extent, been met using model-based drug development. Pharmacometrics is a part of pharmacology that quantifies drug behaviour, treatment response and disease progression based on different models (pharmacokinetic - PK, pharmacodynamic - PD, PK/PD models, etc.) and simulations. Regulatory bodies (European Medicines Agency, Food and Drug Administration) encourage the use of modelling and simulations to facilitate decision-making throughout all drug development phases. Moreover, the identification of factors that contribute to variability provides a basis for dose individualisation in routine clinical practice. This review summarises current knowledge regarding the application of pharmacometrics in drug development and clinical practice with emphasis on the population modelling approach. AB - Usled čestih neuspeha u kliničkim ispitivanjima i posledično manjeg broja odobrenja novih lekova, potreba za poboljšanjem u razvoju lekova je u određenoj meri zadovoljena korišćenjem pristupa razvoja lekova zasnovanog na modelu. Farmakometrija predstavlja granu farmakologije koja kvantifikuje ponašanje leka, odgovor na terapiju i napredovanje bolesti na osnovu različitih modela (farmakokinetički - FK, farmakodinamički - FD, FK/FD modeli itd.) i simulacija. Regulatorna tela (Evropska agencija za lekove, Uprava za hranu i lekove) podstiču primenu modelovanja i simulacija u svrhu lakšeg donošenja odluka tokom svih faza razvoja lekova. Štaviše, identifikacija faktora koji doprinose varijabilnosti predstavlja osnovu za individualizaciju doze u rutinskoj kliničkoj praksi. Ovaj revijalni rad sumira trenutno znanje u vezi sa primenom farmakometrije u razvoju lekova i kliničkoj praksi sa fokusom na populacionu analizu. PB - Beograd : Savez farmaceutskih udruženja Srbije T2 - Arhiv za farmaciju T1 - Concept and utility of population pharmacokinetic and pharmacokinetic/ pharmacodynamic models in drug development and clinical practice T1 - Koncept i upotreba populacionih farmakokinetičkih i farmakokinetičko/farmakodinamičkih modela u razvoju leka i kliničkoj praksi VL - 71 IS - 4 SP - 336 EP - 353 DO - 10.5937/arhfarm71-32901 ER -
@article{ author = "Roganović, Maša and Homšek, Ana and Jovanović, Marija and Topić-Vučenović, Valentina and Ćulafić, Milica and Miljković, Branislava and Vučićević, Katarina", year = "2021", abstract = "Due to frequent clinical trial failures and consequently fewer new drug approvals, the need for improvement in drug development has, to a certain extent, been met using model-based drug development. Pharmacometrics is a part of pharmacology that quantifies drug behaviour, treatment response and disease progression based on different models (pharmacokinetic - PK, pharmacodynamic - PD, PK/PD models, etc.) and simulations. Regulatory bodies (European Medicines Agency, Food and Drug Administration) encourage the use of modelling and simulations to facilitate decision-making throughout all drug development phases. Moreover, the identification of factors that contribute to variability provides a basis for dose individualisation in routine clinical practice. This review summarises current knowledge regarding the application of pharmacometrics in drug development and clinical practice with emphasis on the population modelling approach., Usled čestih neuspeha u kliničkim ispitivanjima i posledično manjeg broja odobrenja novih lekova, potreba za poboljšanjem u razvoju lekova je u određenoj meri zadovoljena korišćenjem pristupa razvoja lekova zasnovanog na modelu. Farmakometrija predstavlja granu farmakologije koja kvantifikuje ponašanje leka, odgovor na terapiju i napredovanje bolesti na osnovu različitih modela (farmakokinetički - FK, farmakodinamički - FD, FK/FD modeli itd.) i simulacija. Regulatorna tela (Evropska agencija za lekove, Uprava za hranu i lekove) podstiču primenu modelovanja i simulacija u svrhu lakšeg donošenja odluka tokom svih faza razvoja lekova. Štaviše, identifikacija faktora koji doprinose varijabilnosti predstavlja osnovu za individualizaciju doze u rutinskoj kliničkoj praksi. Ovaj revijalni rad sumira trenutno znanje u vezi sa primenom farmakometrije u razvoju lekova i kliničkoj praksi sa fokusom na populacionu analizu.", publisher = "Beograd : Savez farmaceutskih udruženja Srbije", journal = "Arhiv za farmaciju", title = "Concept and utility of population pharmacokinetic and pharmacokinetic/ pharmacodynamic models in drug development and clinical practice, Koncept i upotreba populacionih farmakokinetičkih i farmakokinetičko/farmakodinamičkih modela u razvoju leka i kliničkoj praksi", volume = "71", number = "4", pages = "336-353", doi = "10.5937/arhfarm71-32901" }
Roganović, M., Homšek, A., Jovanović, M., Topić-Vučenović, V., Ćulafić, M., Miljković, B.,& Vučićević, K.. (2021). Concept and utility of population pharmacokinetic and pharmacokinetic/ pharmacodynamic models in drug development and clinical practice. in Arhiv za farmaciju Beograd : Savez farmaceutskih udruženja Srbije., 71(4), 336-353. https://doi.org/10.5937/arhfarm71-32901
Roganović M, Homšek A, Jovanović M, Topić-Vučenović V, Ćulafić M, Miljković B, Vučićević K. Concept and utility of population pharmacokinetic and pharmacokinetic/ pharmacodynamic models in drug development and clinical practice. in Arhiv za farmaciju. 2021;71(4):336-353. doi:10.5937/arhfarm71-32901 .
Roganović, Maša, Homšek, Ana, Jovanović, Marija, Topić-Vučenović, Valentina, Ćulafić, Milica, Miljković, Branislava, Vučićević, Katarina, "Concept and utility of population pharmacokinetic and pharmacokinetic/ pharmacodynamic models in drug development and clinical practice" in Arhiv za farmaciju, 71, no. 4 (2021):336-353, https://doi.org/10.5937/arhfarm71-32901 . .