A critical review on approaches to generate and validate virtual population for physiologically based pharmacokinetic models: Methodologies, case studies and way forward.
Purpose: In silico modeling and simulation techniques such as physiologically based pharmacokinetic (PBPK) and physiologically based biopharmaceutics modeling (PBBM) have demonstrated various applications in drug discovery and development. Virtual bioequivalence leverages these computation tools to...
| Publicado en: | European Journal of Clinical Pharmacology Vol. 80; no. 12; pp. 1903 - 1923 |
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| Autores principales: | , , , |
| Formato: | equations & formulas review tables/charts Journal Article |
| Publicado: |
Springer Nature
Dec2024
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=182280348&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 182280348 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 00316970 NP9 jtl: European Journal of Clinical Pharmacology issn: 00316970 maglogo: N pubinfo: dt: Dec2024 vid: 80 iid: 12 pid: 237 pub: Springer Nature place: New York, New York artinfo: ui: 182280348 180147086 182280348 182280348 10.1007/s00228-024-03763-w 182280348 ppf: 1903 ppct: 20 formats: fmt: – @attributes: type: T – @attributes: type: P tig: atl: A critical review on approaches to generate and validate virtual population for physiologically based pharmacokinetic models: Methodologies, case studies and way forward. aug: au: Chougule, Mahendra Kollipara, Sivacharan Mondal, Smritilekha Ahmed, Tausif affil: https://ror.org/01rkxa860 Biopharmaceutics Group, Global Clinical Management, Dr. Reddy's Laboratories Ltd., Integrated Product Development Organization (IPDO), Bachupally, Medchal Malkajgiri District, 500 090, Hyderabad, Telangana, India sug: subj: Models, Biological Pharmacokinetics Biological Availability Drugs, Generic Computer Simulation Drug Discovery Bioinformatics Software Research, Medical Methods ab: Purpose: In silico modeling and simulation techniques such as physiologically based pharmacokinetic (PBPK) and physiologically based biopharmaceutics modeling (PBBM) have demonstrated various applications in drug discovery and development. Virtual bioequivalence leverages these computation tools to predict bioequivalence between reference and test formulations thereby demonstrating possibilities to reduce human studies. A pre-requisite for virtual bioequivalence is development of validated virtual population that depicts the same variability as that of observed in clinic. This development, validation and optimization of virtual population is a key attribute of virtual bioequivalence based on which conclusion of bioequivalence is made. Methods: Various strategies for optimization of virtual population based on appropriate considerations of physicochemical, physiological and disposition aspects are demonstrated with the help of six diverse case studies of immediate and modified release formulations. Once the virtual population is optimized to match in vivo variability, it can be used for various applications such as biowaivers, dissolution specification justification, f2 mismatch, establishing dissolution safe space, etc. In this review article, we attempted to describe various methodologies and approaches for optimization of virtual population using Gastroplus. Results: Strategies based on optimization of virtual population with emphasis on specific and sensitive parameters were portrayed. We have further elucidated considerations related to study design, in vivo variability, sample size for optimization of virtual population from Gastroplus perspective. Conclusion: We believe that this review article provides a step-by-step process for virtual population optimization for interest of biopharmaceutics modeling scientists in order to ensure reliable and credible physiological models. pubtype: Academic Journal doctype: equations & formulas review tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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