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

Uloga fiziološki-zasnovanog farmakokinetičkog/biofarmaceutskog modelovanja u razvoju farmaceutskih preparata

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2021
The_emerging_role_pub_2021.pdf (1.411Mb)
Authors
Cvijić, Sandra
Ignjatović, Jelisaveta
Parojčić, Jelena
Ibrić, Svetlana
Article (Published version)
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Abstract
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 GastroPl...us™, 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.

Računarski podržano (in silico) modelovanje se danas koristi u različitim oblastima farmaceutskih nauka, sa širokom paletom primene. Kao jedan od in silico alata, fiziološki zasnovano farmakokinetičko/biofarmaceutsko modelovanje (PBPK/PBBM) se pokazalo posebno korisnim u razvoju farmaceutskih preparata. Strategije zasnovane na PBPK/PBBM modelovanju se poslednjih godina sve više razmatraju, što se vidi iz izveštaja farmaceutskih kompanija i velikog broja publikovanih istraživačkih i revijalnih radova na ovu temu. Takođe, vodeće regulatorne agencije su nedavno izdale vodiče koji se odnose na primenu PBPK modelovanja u razvoju farmaceutskih preparata. In silico PBPK modelovanje je primenjivo za različite puteve primene leka (peroralni, (intra)oralni, parenteralni, inhalacioni, okularni, dermalni itd), mada se najveći broj primera iz literature odnosi na modelovanje bioperformansi peroralno primenjenih lekova. Kako bi olakšale primenu PBPK modelovanja, nekoliko kompanija je razvilo komerci...jalno dostupne programske pakete, kao što su GastroPlus™, Simcyp™ PBPK Simulator i PK-Sim®. U ovom radu su istaknute različite mogućnosti primene PBPK/PBBM modelovanja, uključujući osnovne principe, prednosti i ograničenja. Takođe, prikazani su odgovarajući primeri koji opisuju praktičnu primenu modelovanja i simulacija u različitim fazama razvoja leka.

Keywords:
Physiologically-based pharmacokinetic modeling (PBPK) / physiologically-based biopharmaceutics modeling (PBBM) / model informed drug development (MIDD) / drug bioperformance / fiziološki zasnovano farmakokinetičko modelovanje (PBPK) / fiziološki zasnovano biofarmaceutsko modelovanje (PBBM) / model zasnovan razvoj lekova (MIDD) / bioperformanse lekova
Source:
Arhiv za farmaciju, 2021, 71, 4, 318-335
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/arhfarm71-32479

ISSN: 0004-1963

[ Google Scholar ]
URI
https://farfar.pharmacy.bg.ac.rs/handle/123456789/3959
Collections
  • Radovi istraživača / Researchers’ publications
Institution/Community
Pharmacy
TY  - JOUR
AU  - Cvijić, Sandra
AU  - Ignjatović, Jelisaveta
AU  - Parojčić, Jelena
AU  - Ibrić, Svetlana
PY  - 2021
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/3959
AB  - 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.
AB  - Računarski podržano (in silico) modelovanje se danas koristi u različitim oblastima farmaceutskih nauka, sa širokom paletom primene. Kao jedan od in silico alata, fiziološki zasnovano farmakokinetičko/biofarmaceutsko modelovanje (PBPK/PBBM) se pokazalo posebno korisnim u razvoju farmaceutskih preparata. Strategije zasnovane na PBPK/PBBM modelovanju se poslednjih godina sve više razmatraju, što se vidi iz izveštaja farmaceutskih kompanija i velikog broja publikovanih istraživačkih i revijalnih radova na ovu temu. Takođe, vodeće regulatorne agencije su nedavno izdale vodiče koji se odnose na primenu PBPK modelovanja u razvoju farmaceutskih preparata. In silico PBPK modelovanje je primenjivo za različite puteve primene leka (peroralni, (intra)oralni, parenteralni, inhalacioni, okularni, dermalni itd), mada se najveći broj primera iz literature odnosi na modelovanje bioperformansi peroralno primenjenih lekova. Kako bi olakšale primenu PBPK modelovanja, nekoliko kompanija je razvilo komercijalno dostupne programske pakete, kao što su GastroPlus™, Simcyp™ PBPK Simulator i PK-Sim®. U ovom radu su istaknute različite mogućnosti primene PBPK/PBBM modelovanja, uključujući osnovne principe, prednosti i ograničenja. Takođe, prikazani su odgovarajući primeri koji opisuju praktičnu primenu modelovanja i simulacija u različitim fazama razvoja leka.
PB  - Beograd : Savez farmaceutskih udruženja Srbije
T2  - Arhiv za farmaciju
T1  - The emerging role of physiologically-based pharmacokinetic/biopharmaceutics modeling in formulation development
T1  - Uloga fiziološki-zasnovanog farmakokinetičkog/biofarmaceutskog modelovanja u razvoju farmaceutskih preparata
VL  - 71
IS  - 4
SP  - 318
EP  - 335
DO  - 10.5937/arhfarm71-32479
ER  - 
@article{
author = "Cvijić, Sandra and Ignjatović, Jelisaveta and Parojčić, Jelena and Ibrić, Svetlana",
year = "2021",
abstract = "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., Računarski podržano (in silico) modelovanje se danas koristi u različitim oblastima farmaceutskih nauka, sa širokom paletom primene. Kao jedan od in silico alata, fiziološki zasnovano farmakokinetičko/biofarmaceutsko modelovanje (PBPK/PBBM) se pokazalo posebno korisnim u razvoju farmaceutskih preparata. Strategije zasnovane na PBPK/PBBM modelovanju se poslednjih godina sve više razmatraju, što se vidi iz izveštaja farmaceutskih kompanija i velikog broja publikovanih istraživačkih i revijalnih radova na ovu temu. Takođe, vodeće regulatorne agencije su nedavno izdale vodiče koji se odnose na primenu PBPK modelovanja u razvoju farmaceutskih preparata. In silico PBPK modelovanje je primenjivo za različite puteve primene leka (peroralni, (intra)oralni, parenteralni, inhalacioni, okularni, dermalni itd), mada se najveći broj primera iz literature odnosi na modelovanje bioperformansi peroralno primenjenih lekova. Kako bi olakšale primenu PBPK modelovanja, nekoliko kompanija je razvilo komercijalno dostupne programske pakete, kao što su GastroPlus™, Simcyp™ PBPK Simulator i PK-Sim®. U ovom radu su istaknute različite mogućnosti primene PBPK/PBBM modelovanja, uključujući osnovne principe, prednosti i ograničenja. Takođe, prikazani su odgovarajući primeri koji opisuju praktičnu primenu modelovanja i simulacija u različitim fazama razvoja leka.",
publisher = "Beograd : Savez farmaceutskih udruženja Srbije",
journal = "Arhiv za farmaciju",
title = "The emerging role of physiologically-based pharmacokinetic/biopharmaceutics modeling in formulation development, Uloga fiziološki-zasnovanog farmakokinetičkog/biofarmaceutskog modelovanja u razvoju farmaceutskih preparata",
volume = "71",
number = "4",
pages = "318-335",
doi = "10.5937/arhfarm71-32479"
}
Cvijić, S., Ignjatović, J., Parojčić, J.,& Ibrić, S.. (2021). The emerging role of physiologically-based pharmacokinetic/biopharmaceutics modeling in formulation development. in Arhiv za farmaciju
Beograd : Savez farmaceutskih udruženja Srbije., 71(4), 318-335.
https://doi.org/10.5937/arhfarm71-32479
Cvijić S, Ignjatović J, Parojčić J, Ibrić S. The emerging role of physiologically-based pharmacokinetic/biopharmaceutics modeling in formulation development. in Arhiv za farmaciju. 2021;71(4):318-335.
doi:10.5937/arhfarm71-32479 .
Cvijić, Sandra, Ignjatović, Jelisaveta, Parojčić, Jelena, Ibrić, Svetlana, "The emerging role of physiologically-based pharmacokinetic/biopharmaceutics modeling in formulation development" in Arhiv za farmaciju, 71, no. 4 (2021):318-335,
https://doi.org/10.5937/arhfarm71-32479 . .

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