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The models provided have been collated from published examples which authors have shared in our Published Model Collection or developed as part of various global health projects in our Global Health Collection. This search facility searches both model collections simultaneously.

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Found 118 Matches

Praziquantel

Model Files Publication

Brand Name(s) include: Biltricide, Cysticide, Praquantel

Indication: Schistosomiasis and clonorchiasis/opisthorchiasis due to the liver flukes

Drug Class: Anthelmintic

Version: 22

Date Updated: February 2024

The model at-a-glance

Absorption Model	ADAM, solid IR dosage form, permeability predicted by Caco-2 data, basolateral permeability scalar incorporated
Volume of Distribution Details	Full model (method 3)
Route of Elimination	fm_CYP3A4= 43.6, fm_CYP1A2 = 41.4, fm_CYP2C19 = 15.0
Perpetrator DDI	Not included
Validation	Model performance was verified in healthy adult volunteers and pediatric schistosomiasis patients. Eight clinical studies in adults (20 to 50 mg/kg PO) and one clinical study in children (20 to 60 mg/kg PO) were used for model verification. Across the adult healthy volunteer studies, eighteen of twenty-five simulated C_max values and twenty-one of twenty-five simulated AUC values were within 2-fold of the observed data. For the pediatric study in schistosomiasis patients, eleven of twelve simulated C_max and AUC values were within 2-fold of the observed data. The fm_CYP3A4was verified through simulations of prazaquantel in the presence versus the absence of ketoconazole and rifampicin.
Limitations	Model was developed using 20 mg/kg and 40 mg/kg PO adult data. Use of 20 to 50 mg/kg PO (healthy adult volunteers) and 20 to 60 mg/kg PO (pediatric schistosomiasis patients) were verified. Utility of the model outside these dose ranges is not confirmed. Model assumes all CYP3A-dependent clearance is mediated by CYP3A4 (i.e., CYP3A5 is not included in the model) Model is not verified for use as victim of CYP1A2 and CYP2C19 interactions

Search Score: 1

Aripiprazole_V12R2_USFDA_20160510

Model Files Publication

Note: additional dissolution data 0.5 hr 55% not captured in the supplemental materials of the publication

Search Score: 1

Fenebrutinib_V19R1_Pfizer_20210804

Model Files Publication

An optimized Rosuvastatin (V19) model was used and DDIs predominantly driven by gut BCRP inhibition are reasonably recovered. Altogether, the following inhibitors were used: Capmatinib Fenebrutinib Fostamatinib Itraconazole Zepatier The workspace represents the DDI between Rosuvastatin and Fenebrutinib. Notes: - The fuGut in the inhibitor file is set as user input to 1. - An additional systemic clearance of 1.1 L/h is included in the submitted file. Link to the publication with further details: http://doi.org/10.1002/psp4.12672

Search Score: 1

Hyperforin_V17R1_UniversityOfSydney_20190131

Model Files Publication

The submitted compound file describes the PBPK model for hyperforin (from St John's wort extract). The PBPK model implements first-order absorption model, full-PBPK (method 2) for its distribution and total CLint in HLM (whole organ metabolic clearance) calculated by the retrograde approach. The model accounts for the induction of CYP3A4, 2C9 and 2C19. It has been verified using the healthy population library available in Simcyp SImulator by default. The predictive performance of this model to predict herb-drug interactions with St John's wort was evaluated across a range of CYP substrates as detailed in the publication. https://link.springer.com/article/10.1007%2Fs40262-019-00736-6

Search Score: 1

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Praziquantel

The model at-a-glance

Aripiprazole_V12R2_USFDA_20160510

Fenebrutinib_V19R1_Pfizer_20210804

Hyperforin_V17R1_UniversityOfSydney_20190131

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