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pbpk models for midazolam  (Simcyp)

 
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    Structured Review

    Simcyp pbpk models for midazolam
    Key <t>PBPK</t> modelling steps and components of each clinical study used in model development, refinement, verification and application. BCRP, breast cancer resistance protein; DDI, drug–drug interaction; fu inc , fraction of unbound dersimelagon in in vitro system; K m , Michaelis constant; MAD, multiple ascending dose; OATP, organic anion transporting polypeptide; PBPK, physiologically based pharmacokinetic; PK, pharmacokinetic; QD, once daily; V max , maximum velocity of reaction; V ss , volume of distribution at steady state.
    Pbpk Models For Midazolam, supplied by Simcyp, used in various techniques. Bioz Stars score: 90/100, based on 1 PubMed citations. ZERO BIAS - scores, article reviews, protocol conditions and more
    https://www.bioz.com/product/midazolam+pbpk+model/midazolam+pbpk+model/pmc11773107-216-1-17
    Average 90 stars, based on 1 article reviews
    pbpk models for midazolam - by Bioz Stars, 2026-09
    90/100 stars

    Images

    1) Product Images from "Physiologically based pharmacokinetic modelling to predict potential drug–drug interactions of dersimelagon (MT‐7117)"

    Article Title: Physiologically based pharmacokinetic modelling to predict potential drug–drug interactions of dersimelagon (MT‐7117)

    Journal: British Journal of Clinical Pharmacology

    doi: 10.1111/bcp.16271

    Key PBPK modelling steps and components of each clinical study used in model development, refinement, verification and application. BCRP, breast cancer resistance protein; DDI, drug–drug interaction; fu inc , fraction of unbound dersimelagon in in vitro system; K m , Michaelis constant; MAD, multiple ascending dose; OATP, organic anion transporting polypeptide; PBPK, physiologically based pharmacokinetic; PK, pharmacokinetic; QD, once daily; V max , maximum velocity of reaction; V ss , volume of distribution at steady state.
    Figure Legend Snippet: Key PBPK modelling steps and components of each clinical study used in model development, refinement, verification and application. BCRP, breast cancer resistance protein; DDI, drug–drug interaction; fu inc , fraction of unbound dersimelagon in in vitro system; K m , Michaelis constant; MAD, multiple ascending dose; OATP, organic anion transporting polypeptide; PBPK, physiologically based pharmacokinetic; PK, pharmacokinetic; QD, once daily; V max , maximum velocity of reaction; V ss , volume of distribution at steady state.

    Techniques Used: In Vitro

    Input parameters of the physiologically based pharmacokinetic model for dersimelagon.
    Figure Legend Snippet: Input parameters of the physiologically based pharmacokinetic model for dersimelagon.

    Techniques Used: Binding Assay, Software, Permeability, In Vitro, Inhibition

    Related Articles

    other:

    Article Title: Model-Based Assessments of CYP-Mediated Drug-Drug Interaction Risk of Alectinib: Physiologically Based Pharmacokinetic Modeling Supported Clinical Development.
    Article Snippet: Alectinib is a selective anaplastic lymphoma kinase (ALK) inhibitor approved for the treatment of ALK-positive non-small cell lung cancer.. Alectinib and its major active metabolite M4 exhibited drug–drug interaction (DDI) potential through cytochrome P450 (CYP) enzymes CYP3A4 and CYP2C8 in vitro.. Clinical relevance of the DDI risk was investigated as part of a rapid development program to fulfill the breakthrough therapy designation.

    Activity Assay:

    Article Title: Use of Physiologically Based Pharmacokinetic Modeling to Evaluate the Impact of Chronic Kidney Disease on CYP3A4‐Mediated Metabolism of Saxagliptin
    Article Snippet: .. We conducted PBPK modeling of midazolam with decreased and preserved CYP3A4 activity simulations using the validated midazolam PBPK model within the Simcyp repository and observed that preserved CYP3A4 simulations of midazolam predicted PK in all CKD populations better than that with simulations with decreased CYP3A4 (Table ). ..



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    pbpk models for midazolam  (Simcyp)
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    Simcyp pbpk models for midazolam
    Key <t>PBPK</t> modelling steps and components of each clinical study used in model development, refinement, verification and application. BCRP, breast cancer resistance protein; DDI, drug–drug interaction; fu inc , fraction of unbound dersimelagon in in vitro system; K m , Michaelis constant; MAD, multiple ascending dose; OATP, organic anion transporting polypeptide; PBPK, physiologically based pharmacokinetic; PK, pharmacokinetic; QD, once daily; V max , maximum velocity of reaction; V ss , volume of distribution at steady state.
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    (a) Regional distribution of OATP1B across the hepatic lobule from the portal vein (PV) to the central vein (CV). (b) Schematic representation of the permeability‐limited multi‐compartment liver (PerMCL) as part of a whole‐body physiologically based pharmacokinetic model within the Simcyp Simulator. (c) Workflow of drug–drug interaction (DDI) modeling framework using the matrix approach. (d) Schematic of drug–drug interaction (DDI) network with rifampicin (RIF), repaglinide (RPG), trimethoprim (TMP), cyclosporine (CsA), <t>midazolam</t> (MDZ), and pravastatin (PRV). Cu EW , concentration of unbound drug in extracellular water; Cu IW , concentration of unbound drug in intracellular water; CYP, cytochrome P450; OATP, organic anion transporting polypeptide; MRP, multidrug resistance‐associated protein. Created with BioRender.com .
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    (a) Regional distribution of OATP1B across the hepatic lobule from the portal vein (PV) to the central vein (CV). (b) Schematic representation of the permeability‐limited multi‐compartment liver (PerMCL) as part of a whole‐body physiologically based pharmacokinetic model within the Simcyp Simulator. (c) Workflow of drug–drug interaction (DDI) modeling framework using the matrix approach. (d) Schematic of drug–drug interaction (DDI) network with rifampicin (RIF), repaglinide (RPG), trimethoprim (TMP), cyclosporine (CsA), <t>midazolam</t> (MDZ), and pravastatin (PRV). Cu EW , concentration of unbound drug in extracellular water; Cu IW , concentration of unbound drug in intracellular water; CYP, cytochrome P450; OATP, organic anion transporting polypeptide; MRP, multidrug resistance‐associated protein. Created with BioRender.com .
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    default pbpk model for midazolam  (Simcyp)
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    (a) Regional distribution of OATP1B across the hepatic lobule from the portal vein (PV) to the central vein (CV). (b) Schematic representation of the permeability‐limited multi‐compartment liver (PerMCL) as part of a whole‐body physiologically based pharmacokinetic model within the Simcyp Simulator. (c) Workflow of drug–drug interaction (DDI) modeling framework using the matrix approach. (d) Schematic of drug–drug interaction (DDI) network with rifampicin (RIF), repaglinide (RPG), trimethoprim (TMP), cyclosporine (CsA), <t>midazolam</t> (MDZ), and pravastatin (PRV). Cu EW , concentration of unbound drug in extracellular water; Cu IW , concentration of unbound drug in intracellular water; CYP, cytochrome P450; OATP, organic anion transporting polypeptide; MRP, multidrug resistance‐associated protein. Created with BioRender.com .
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    Image Search Results


    Key PBPK modelling steps and components of each clinical study used in model development, refinement, verification and application. BCRP, breast cancer resistance protein; DDI, drug–drug interaction; fu inc , fraction of unbound dersimelagon in in vitro system; K m , Michaelis constant; MAD, multiple ascending dose; OATP, organic anion transporting polypeptide; PBPK, physiologically based pharmacokinetic; PK, pharmacokinetic; QD, once daily; V max , maximum velocity of reaction; V ss , volume of distribution at steady state.

    Journal: British Journal of Clinical Pharmacology

    Article Title: Physiologically based pharmacokinetic modelling to predict potential drug–drug interactions of dersimelagon (MT‐7117)

    doi: 10.1111/bcp.16271

    Figure Lengend Snippet: Key PBPK modelling steps and components of each clinical study used in model development, refinement, verification and application. BCRP, breast cancer resistance protein; DDI, drug–drug interaction; fu inc , fraction of unbound dersimelagon in in vitro system; K m , Michaelis constant; MAD, multiple ascending dose; OATP, organic anion transporting polypeptide; PBPK, physiologically based pharmacokinetic; PK, pharmacokinetic; QD, once daily; V max , maximum velocity of reaction; V ss , volume of distribution at steady state.

    Article Snippet: The PBPK models for other substrate drugs, including midazolam, digoxin, pravastatin and atorvastatin, are included in the Simcyp Compound Database.

    Techniques: In Vitro

    Input parameters of the physiologically based pharmacokinetic model for dersimelagon.

    Journal: British Journal of Clinical Pharmacology

    Article Title: Physiologically based pharmacokinetic modelling to predict potential drug–drug interactions of dersimelagon (MT‐7117)

    doi: 10.1111/bcp.16271

    Figure Lengend Snippet: Input parameters of the physiologically based pharmacokinetic model for dersimelagon.

    Article Snippet: The PBPK models for other substrate drugs, including midazolam, digoxin, pravastatin and atorvastatin, are included in the Simcyp Compound Database.

    Techniques: Binding Assay, Software, Permeability, In Vitro, Inhibition

    (a) Regional distribution of OATP1B across the hepatic lobule from the portal vein (PV) to the central vein (CV). (b) Schematic representation of the permeability‐limited multi‐compartment liver (PerMCL) as part of a whole‐body physiologically based pharmacokinetic model within the Simcyp Simulator. (c) Workflow of drug–drug interaction (DDI) modeling framework using the matrix approach. (d) Schematic of drug–drug interaction (DDI) network with rifampicin (RIF), repaglinide (RPG), trimethoprim (TMP), cyclosporine (CsA), midazolam (MDZ), and pravastatin (PRV). Cu EW , concentration of unbound drug in extracellular water; Cu IW , concentration of unbound drug in intracellular water; CYP, cytochrome P450; OATP, organic anion transporting polypeptide; MRP, multidrug resistance‐associated protein. Created with BioRender.com .

    Journal: CPT: Pharmacometrics & Systems Pharmacology

    Article Title: Hepatic OATP1B zonal distribution: Implications for rifampicin‐mediated drug–drug interactions explored within a PBPK framework

    doi: 10.1002/psp4.13188

    Figure Lengend Snippet: (a) Regional distribution of OATP1B across the hepatic lobule from the portal vein (PV) to the central vein (CV). (b) Schematic representation of the permeability‐limited multi‐compartment liver (PerMCL) as part of a whole‐body physiologically based pharmacokinetic model within the Simcyp Simulator. (c) Workflow of drug–drug interaction (DDI) modeling framework using the matrix approach. (d) Schematic of drug–drug interaction (DDI) network with rifampicin (RIF), repaglinide (RPG), trimethoprim (TMP), cyclosporine (CsA), midazolam (MDZ), and pravastatin (PRV). Cu EW , concentration of unbound drug in extracellular water; Cu IW , concentration of unbound drug in intracellular water; CYP, cytochrome P450; OATP, organic anion transporting polypeptide; MRP, multidrug resistance‐associated protein. Created with BioRender.com .

    Article Snippet: The PBPK model for midazolam was the default file within the Simcyp Simulator (Table ).

    Techniques: Permeability, Concentration Assay

    Predicted effect of IL‐6 CYP3A enzyme suppression on PKs of CYP3A substrates in comparison with the observed clinical data.

    Journal: CPT: Pharmacometrics & Systems Pharmacology

    Article Title: Assessment of CYP3A‐mediated drug interaction via cytokine (IL‐6) elevation for mosunetuzumab using physiologically‐based pharmacokinetic modeling

    doi: 10.1002/psp4.13073

    Figure Lengend Snippet: Predicted effect of IL‐6 CYP3A enzyme suppression on PKs of CYP3A substrates in comparison with the observed clinical data.

    Article Snippet: The default PBPK models for midazolam and simvastatin in the Simcyp compound library (Simcyp V17) were used without modifications.

    Techniques: Comparison

    Saxagliptin and 5‐Hydroxysaxagliptin PBPK Model Parameters

    Journal: Journal of Clinical Pharmacology

    Article Title: Use of Physiologically Based Pharmacokinetic Modeling to Evaluate the Impact of Chronic Kidney Disease on CYP3A4‐Mediated Metabolism of Saxagliptin

    doi: 10.1002/jcph.2043

    Figure Lengend Snippet: Saxagliptin and 5‐Hydroxysaxagliptin PBPK Model Parameters

    Article Snippet: We conducted PBPK modeling of midazolam with decreased and preserved CYP3A4 activity simulations using the validated midazolam PBPK model within the Simcyp repository and observed that preserved CYP3A4 simulations of midazolam predicted PK in all CKD populations better than that with simulations with decreased CYP3A4 (Table ).

    Techniques: Molecular Weight