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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

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2021
Concept_and_utility_pub_2021.pdf (483.7Kb)
Authors
Roganović, Maša
Homšek, Ana
Jovanović, Marija
Topić-Vučenović, Valentina
Ćulafić, Milica
Miljković, Branislava
Vučićević, Katarina
Article (Published version)
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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.
Keywords:
Pharmacometrics / population analysis / pharmacokinetics / pharmacokinetic-pharmacodynamic modelling / farmakometrija / populaciona analiza / farmakokinetika / farmakokinetičko-farmakodinamičko modelovanje
Source:
Arhiv za farmaciju, 2021, 71, 4, 336-353
Publisher:
  • Beograd : Savez farmaceutskih udruženja Srbije
Funding / projects:
  • Ministry of Education, Science and Technological Development, Republic of Serbia, Grant no. 200161 (University of Belgrade, Faculty of Pharmacy) (RS-200161)

DOI: 10.5937/arhfarm71-32901

ISSN: 0004-1963

[ Google Scholar ]
URI
https://farfar.pharmacy.bg.ac.rs/handle/123456789/3960
Collections
  • Radovi istraživača / Researchers’ publications
Institution/Community
Pharmacy
TY  - 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 . .

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