Concept and utility of population pharmacokinetic and pharmacokinetic/pharmacodynamic models in drug development and clinical practice

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 dise...

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Autores principales:	Roganović Maša, Homšek Ana, Jovanović Marija, Topić-Vučenović Valentina, Ćulafić Milica, Miljković Branislava, Vučićević Katarina
Formato:	article
Lenguaje:	SR
Publicado:	Pharmaceutical Association of Serbia, Belgrade, Serbia 2021
Materias:	pharmacometrics population analysis pharmacokinetics pharmacokinetic-pharmacodynamic modelling Pharmacy and materia medica RS1-441
Acceso en línea:	https://doaj.org/article/18d1989d14b4472cbfad888840706983
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spelling	oai:doaj.org-article:18d1989d14b4472cbfad8888407069832021-12-05T18:01:35ZConcept and utility of population pharmacokinetic and pharmacokinetic/pharmacodynamic models in drug development and clinical practice0004-19632217-876710.5937/arhfarm71-32901https://doaj.org/article/18d1989d14b4472cbfad8888407069832021-01-01T00:00:00Zhttps://scindeks-clanci.ceon.rs/data/pdf/0004-1963/2021/0004-19632104336R.pdfhttps://doaj.org/toc/0004-1963https://doaj.org/toc/2217-8767Due 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.Roganović MašaHomšek AnaJovanović MarijaTopić-Vučenović ValentinaĆulafić MilicaMiljković BranislavaVučićević KatarinaPharmaceutical Association of Serbia, Belgrade, Serbiaarticlepharmacometricspopulation analysispharmacokineticspharmacokinetic-pharmacodynamic modellingPharmacy and materia medicaRS1-441SRArhiv za farmaciju, Vol 71, Iss 4, Pp 336-353 (2021)
institution	DOAJ
collection	DOAJ
language	SR
topic	pharmacometrics population analysis pharmacokinetics pharmacokinetic-pharmacodynamic modelling Pharmacy and materia medica RS1-441
spellingShingle	pharmacometrics population analysis pharmacokinetics pharmacokinetic-pharmacodynamic modelling Pharmacy and materia medica RS1-441 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
description	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.
format	article
author	Roganović Maša Homšek Ana Jovanović Marija Topić-Vučenović Valentina Ćulafić Milica Miljković Branislava Vučićević Katarina
author_facet	Roganović Maša Homšek Ana Jovanović Marija Topić-Vučenović Valentina Ćulafić Milica Miljković Branislava Vučićević Katarina
author_sort	Roganović Maša
title	Concept and utility of population pharmacokinetic and pharmacokinetic/pharmacodynamic models in drug development and clinical practice
title_short	Concept and utility of population pharmacokinetic and pharmacokinetic/pharmacodynamic models in drug development and clinical practice
title_full	Concept and utility of population pharmacokinetic and pharmacokinetic/pharmacodynamic models in drug development and clinical practice
title_fullStr	Concept and utility of population pharmacokinetic and pharmacokinetic/pharmacodynamic models in drug development and clinical practice
title_full_unstemmed	Concept and utility of population pharmacokinetic and pharmacokinetic/pharmacodynamic models in drug development and clinical practice
title_sort	concept and utility of population pharmacokinetic and pharmacokinetic/pharmacodynamic models in drug development and clinical practice
publisher	Pharmaceutical Association of Serbia, Belgrade, Serbia
publishDate	2021
url	https://doaj.org/article/18d1989d14b4472cbfad888840706983
work_keys_str_mv	AT roganovicmasa conceptandutilityofpopulationpharmacokineticandpharmacokineticpharmacodynamicmodelsindrugdevelopmentandclinicalpractice AT homsekana conceptandutilityofpopulationpharmacokineticandpharmacokineticpharmacodynamicmodelsindrugdevelopmentandclinicalpractice AT jovanovicmarija conceptandutilityofpopulationpharmacokineticandpharmacokineticpharmacodynamicmodelsindrugdevelopmentandclinicalpractice AT topicvucenovicvalentina conceptandutilityofpopulationpharmacokineticandpharmacokineticpharmacodynamicmodelsindrugdevelopmentandclinicalpractice AT culaficmilica conceptandutilityofpopulationpharmacokineticandpharmacokineticpharmacodynamicmodelsindrugdevelopmentandclinicalpractice AT miljkovicbranislava conceptandutilityofpopulationpharmacokineticandpharmacokineticpharmacodynamicmodelsindrugdevelopmentandclinicalpractice AT vucicevickatarina conceptandutilityofpopulationpharmacokineticandpharmacokineticpharmacodynamicmodelsindrugdevelopmentandclinicalpractice
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Concept and utility of population pharmacokinetic and pharmacokinetic/pharmacodynamic models in drug development and clinical practice

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