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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 147 Matches

Pitavastatin_RES_V20R1_Simcyp_20211102

Model Files Publication

The RES-Pitavastatin file was developed as a CYP2C9, UGT1A3/2B7, OATP1B1/1B3/2B1, NTCP substrate This document provides: 1. Examples of model performance 2. A summary of the key pharmacokinetic features of pitavastatin considered within the model.

Search Score: 2

Pyrimethamine

Model Files Publication

Brand Name(s) include: Daraprim

Disease: Malaria

Drug Class: Antimalarials

Date Updated: November 2021

Model at-a-glance

Absorption Model	First-Order
Volume of Distribution	Full PBPK (Method 2) Note: Kp scalar used
Route of Elimination	Non-specific hepatic metabolism (metabolizing enzymes not known)
Perpetrator DDI	OCT1 and OCT2 inhibitor
Validation	Three clinical studies were available for model verification. 100% of simulated Cmax and AUC were within 1.5-fold of observed and hence the model performance was deemed acceptable.
Limitations	The current model does not describe enzyme specific metabolism of pyrimethamine as there are no data for specific routes of metabolism. The current model does not mechanistically describe the absorption of pyrimethamine as the ADAM model over-predicts the extent of absorption. Although pyrimethamine is described as well absorbed in some literature, further analysis of the IV and PO data did not support this.
Updates in V19	Updated in vitrodata fup: 0.085 -> 0.095

Search Score: 2

African Malaria Population V17

Model Files Publication

African Malaria Population V17

Search Score: 2

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: 2

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Pitavastatin_RES_V20R1_Simcyp_20211102

Pyrimethamine

Model at-a-glance

African Malaria Population V17

Praziquantel

The model at-a-glance

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