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Simcyp developed ranitidine compound file. Compound summary included. This was developed as a research file and its current status and limitations are outlined in summary document.
Brand Name(s) include: Fuzeon
Disease: HIV
Drug Class: HIV Entry and Fusion Inhibitor
Date of Review: 2020
Number of Models Reviewed: 1
Number of Models added to the Repository: 1
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Publication |
Pan, X., Stader, F., Abduljalil, K., Gill, K. L., Johnson, T. N., Gardner, I., & Jamei, M. (2020). Development and Application of a Physiologically-Based Pharmacokinetic Model to Predict the Pharmacokinetics of Therapeutic Proteins from Full-term Neonates to Adolescents. The AAPS journal, 22(4), 76. |
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Simcyp Version |
V18 |
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Published Model Application |
Prediction of exposure in noenates |
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Absorption Model |
First Order |
| Volume of Distribution Details |
Full PBPK |
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Route of Elimination |
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Perpetrator DDI |
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Advantages and Limitations |
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Model Compound Files |
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Brand Name: Invirase (hard gel); Fortovase (soft gel)
Disease: HIV
Drug Class: protease inhibitor
Version: 21
Date Updated: March 2024
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Absorption Model |
First order (different absorption parameters for each formulation) |
| Volume of Distribution Details |
Minimal PBPK with Vsac and Q (Method 2) |
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Route of Elimination |
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Perpetrator DDI |
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Validation |
The exposure of 1000mg BID saquinavir with 100 mg BID ritonavir regimen for hard gel were reasonably well recovered (3/3 within 2-fold). With the exception of the 1000 mg BID saquinavir with 100 mg BID ritonavir regimen for soft gel, the exposures of ritonavir-boosted regimens were well recovered (4/5 within 1.5-fold). Ten clinical DDI studies where saquinavir (soft gel) was administered with either ritonavir, cimetidine, ketoconazole, rifampin, erythromycin, or rifabutin were used to verify the PBPK model of saquinavir as a victim. In comparison of predicted vs. observed AUC, 80% of the studies were within 2-fold. Two clinical DDI studies where saquinavir (hard gel) was administered with either ritonavir or nelfinavir were used to verify the PBPK model of saquinavir (hard gel) as a victim. In comparison of predicted vs. observed AUC, 50% of the studies were within 2-fold. Three clinical DDI studies where saquinavir was administered with either midazolam or rifabutin were used to verify the PBPK model of rifabutin (soft gel) as a perpetrator. In comparison of predicted vs. observed AUC, 100% of the studies were within 2-fold. |
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Limitations |
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35 |