13 Feasibility of the pragmatic PBPK modelling approach – towards model-informed dosing in paediatric clinical care
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DOI: 10.1136/archdischild-2023-esdppp.13
Abstract: Introduction More than half of all drugs are still prescribed off-label to children. To support off-label dosing, pharmacokinetic (PK) data are needed. Physiologically-based pharmacokinetic (PBPK) models are increasingly used to study PK and guide dosing… read more here.
Keywords: pragmatic pbpk; pbpk modelling; feasibility pragmatic; model ... See more keywords
Physiologically Based Pharmacokinetic (PBPK) Modelling for In Vitro-In Vivo Extrapolation: Emphasis on the Use of Dissolution Data
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DOI: 10.14227/dt260319p18
Abstract: Recently the pharmaceutical sector has witnessed a drastic rise in the advancement and incorporation of computerbased technology into several unit operations. Drug dissolution profiling is an important consideration for the successful development of immediate and… read more here.
Keywords: dissolution data; based pharmacokinetic; pbpk modelling; physiologically based ... See more keywords
In Vitro/In Vivo Translation of Synergistic Combination of MDM2 and MEK Inhibitors in Melanoma Using PBPK/PD Modelling: Part II
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DOI: 10.3390/ijms231911939
Abstract: The development of in vitro/in vivo translational methods for synergistically acting drug combinations is needed to identify the most effective therapeutic strategies. We performed PBPK/PD modelling for siremadlin, trametinib, and their combination at various dose… read more here.
Keywords: vitro vivo; pbpk modelling; based vitro; combination ... See more keywords
In Vitro/In Vivo Translation of Synergistic Combination of MDM2 and MEK Inhibitors in Melanoma Using PBPK/PD Modelling: Part I
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DOI: 10.3390/ijms232112984
Abstract: Translation of the synergy between the Siremadlin (MDM2 inhibitor) and Trametinib (MEK inhibitor) combination observed in vitro into in vivo synergistic efficacy in melanoma requires estimation of the interaction between these molecules at the pharmacokinetic… read more here.
Keywords: vitro vivo; pbpk modelling; mdm2; combination ... See more keywords
In Vitro/In Vivo Translation of Synergistic Combination of MDM2 and MEK Inhibitors in Melanoma Using PBPK/PD Modelling: Part III
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DOI: 10.3390/ijms24032239
Abstract: The development of in vitro/in vivo translational methods and a clinical trial framework for synergistically acting drug combinations are needed to identify optimal therapeutic conditions with the most effective therapeutic strategies. We performed physiologically based… read more here.
Keywords: vitro vivo; virtual clinical; pbpk modelling; combination ... See more keywords
Application of Modelling and Simulation Approaches to Predict Pharmacokinetics of Therapeutic Monoclonal Antibodies in Pediatric Population
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DOI: 10.3390/pharmaceutics15051552
Abstract: Ethical regulations and limited paediatric participants are key challenges that contribute to a median delay of 6 years in paediatric mAb approval. To overcome these barriers, modelling and simulation methodologies have been adopted to design… read more here.
Keywords: simulation approaches; pbpk modelling; modelling simulation; application modelling ... See more keywords