The emerging role of physiologically-based pharmacokinetic/biopharmaceutics modeling in formulation development

Computer-based (in silico) modeling & simulation tools have been embraced in different fields of pharmaceutics for a variety of applications. Among these, physiologically-based pharmacokinetic/biopharmaceutics modeling (PBPK/PBBM) emerged as a particularly useful tool in formulation development....

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Autores principales:	Cvijić Sandra, Ignjatović Jelisaveta, Parojčić Jelena, Ibrić Svetlana
Formato:	article
Lenguaje:	SR
Publicado:	Pharmaceutical Association of Serbia, Belgrade, Serbia 2021
Materias:	physiologically-based pharmacokinetic modeling (pbpk) physiologically-based biopharmaceutics modeling (pbbm) model informed drug development (midd) drug bioperformance Pharmacy and materia medica RS1-441
Acceso en línea:	https://doaj.org/article/c821d7df8afc493597f1f37cce3ff794
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spelling	oai:doaj.org-article:c821d7df8afc493597f1f37cce3ff7942021-12-05T18:01:35ZThe emerging role of physiologically-based pharmacokinetic/biopharmaceutics modeling in formulation development0004-19632217-876710.5937/arhfarm71-32479https://doaj.org/article/c821d7df8afc493597f1f37cce3ff7942021-01-01T00:00:00Zhttps://scindeks-clanci.ceon.rs/data/pdf/0004-1963/2021/0004-19632104318C.pdfhttps://doaj.org/toc/0004-1963https://doaj.org/toc/2217-8767Computer-based (in silico) modeling & simulation tools have been embraced in different fields of pharmaceutics for a variety of applications. Among these, physiologically-based pharmacokinetic/biopharmaceutics modeling (PBPK/PBBM) emerged as a particularly useful tool in formulation development. PBPK/PBBM facilitated strategies have been increasingly evaluated over the past few years, as demonstrated by several reports from the pharmaceutical industry, and a number of research and review papers on this subject. Also, the leading regulatory authorities have recently issued guidance on the use of PBPK modeling in formulation design. In silico PBPK models can comprise different dosing routes (oral, intraoral, parenteral, inhalation, ocular, dermal etc.), although the majority of published examples refer to modeling of oral drugs performance. In order to facilitate the use of PBPK modeling tools, a couple of companies have launched commercially available software such as GastroPlus™, Simcyp™ PBPK Simulator and PK-Sim®. This paper highlights various application fields of PBPK/PBBM modeling, along with the basic principles, advantages and limitations of this approach, and provides relevant examples to demonstrate the practical utility of modeling & simulation tools in different stages of formulation development.Cvijić SandraIgnjatović JelisavetaParojčić JelenaIbrić SvetlanaPharmaceutical Association of Serbia, Belgrade, Serbiaarticlephysiologically-based pharmacokinetic modeling (pbpk)physiologically-based biopharmaceutics modeling (pbbm)model informed drug development (midd)drug bioperformancePharmacy and materia medicaRS1-441SRArhiv za farmaciju, Vol 71, Iss 4, Pp 318-335 (2021)
institution	DOAJ
collection	DOAJ
language	SR
topic	physiologically-based pharmacokinetic modeling (pbpk) physiologically-based biopharmaceutics modeling (pbbm) model informed drug development (midd) drug bioperformance Pharmacy and materia medica RS1-441
spellingShingle	physiologically-based pharmacokinetic modeling (pbpk) physiologically-based biopharmaceutics modeling (pbbm) model informed drug development (midd) drug bioperformance Pharmacy and materia medica RS1-441 Cvijić Sandra Ignjatović Jelisaveta Parojčić Jelena Ibrić Svetlana The emerging role of physiologically-based pharmacokinetic/biopharmaceutics modeling in formulation development
description	Computer-based (in silico) modeling & simulation tools have been embraced in different fields of pharmaceutics for a variety of applications. Among these, physiologically-based pharmacokinetic/biopharmaceutics modeling (PBPK/PBBM) emerged as a particularly useful tool in formulation development. PBPK/PBBM facilitated strategies have been increasingly evaluated over the past few years, as demonstrated by several reports from the pharmaceutical industry, and a number of research and review papers on this subject. Also, the leading regulatory authorities have recently issued guidance on the use of PBPK modeling in formulation design. In silico PBPK models can comprise different dosing routes (oral, intraoral, parenteral, inhalation, ocular, dermal etc.), although the majority of published examples refer to modeling of oral drugs performance. In order to facilitate the use of PBPK modeling tools, a couple of companies have launched commercially available software such as GastroPlus™, Simcyp™ PBPK Simulator and PK-Sim®. This paper highlights various application fields of PBPK/PBBM modeling, along with the basic principles, advantages and limitations of this approach, and provides relevant examples to demonstrate the practical utility of modeling & simulation tools in different stages of formulation development.
format	article
author	Cvijić Sandra Ignjatović Jelisaveta Parojčić Jelena Ibrić Svetlana
author_facet	Cvijić Sandra Ignjatović Jelisaveta Parojčić Jelena Ibrić Svetlana
author_sort	Cvijić Sandra
title	The emerging role of physiologically-based pharmacokinetic/biopharmaceutics modeling in formulation development
title_short	The emerging role of physiologically-based pharmacokinetic/biopharmaceutics modeling in formulation development
title_full	The emerging role of physiologically-based pharmacokinetic/biopharmaceutics modeling in formulation development
title_fullStr	The emerging role of physiologically-based pharmacokinetic/biopharmaceutics modeling in formulation development
title_full_unstemmed	The emerging role of physiologically-based pharmacokinetic/biopharmaceutics modeling in formulation development
title_sort	emerging role of physiologically-based pharmacokinetic/biopharmaceutics modeling in formulation development
publisher	Pharmaceutical Association of Serbia, Belgrade, Serbia
publishDate	2021
url	https://doaj.org/article/c821d7df8afc493597f1f37cce3ff794
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The emerging role of physiologically-based pharmacokinetic/biopharmaceutics modeling in formulation development

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