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editorial bug fixes
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sfrechen committed Jun 12, 2020
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4 changes: 2 additions & 2 deletions Qualification/Input/Content/Erythromycin-Triazolam-DDI.md
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The release of the snapshot containing the respective simulations can be found here:
https://github.com/Open-Systems-Pharmacology/Erythromycin-Alprazolam-DDI/releases/tag/v1.0.
https://github.com/Open-Systems-Pharmacology/Erythromycin-Triazolam-DDI/releases/tag/v1.0.

The erythromycin-alprazolam interaction was evaluated using two clinical DDI studies ([Greenblatt 1998](#4-References), [Phillips 1986](#4-References)).
The erythromycin-triazolam interaction was evaluated using two clinical DDI studies ([Greenblatt 1998](#4-References), [Phillips 1986](#4-References)).



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2 changes: 1 addition & 1 deletion Qualification/Input/Content/Fluvoxamine-Alprazolam-DDI.md
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The release of the snapshot containing the respective simulations can be found here:
https://github.com/Open-Systems-Pharmacology/Fluvoxamine-Alprazolam-DDI/releases/tag/v1.0.

The fluvoxamine-alprazolam interaction was evaluated using one clinical DDI study quantifying the interaction following the first dose and in steady-state different doses ([Fleishaker 1994](#4-References)).
The fluvoxamine-alprazolam interaction was evaluated using one clinical DDI study quantifying the interaction following the first dose and in steady-state ([Fleishaker 1994](#4-References)).



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2 changes: 1 addition & 1 deletion Qualification/Input/Content/Itraconazole-Alprazolam-DDI.md
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The release of the snapshot containing the respective simulations can be found here:
https://github.com/Open-Systems-Pharmacology/Itraconazole-Alprazolam-DDI/releases/tag/v1.0.

The Itraconazole / alprazolam interaction was evaluated using oneclinical DDI studies ([Yasui 1998](#4-References)).
The itraconazole / alprazolam interaction was evaluated using one clinical DDI study ([Yasui 1998](#4-References)).



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Expand Up @@ -2,7 +2,7 @@ This **qualification report** evaluates for the PBPK platform **PK-Sim** (as par

To demonstrate the level of confidence, the predictive performance of the platform for this indented purpose is assessed via a network of PBPK models of selected index CYP3A4 DDI perpetrators (covering the range from strong induction to strong inhibition), and respective sensitive index CYP3A4 victim drugs and a comprehensive dataset from published clinical DDI studies. All PBPK models represent whole-body PBPK models, which allow dynamic DDI simulations in organs expressing CYP3A4.

The respective *qualification plan* to produce this *qualification report* is transparently documented and provided open-source (www.open-systems-pharmacology.org). The same applies for all presented PBPK models including *evaluation reports* on model building and evaluation of each model.
The respective *qualification plan* to produce this *qualification report* is transparently documented and provided open-source (https://github.com/Open-Systems-Pharmacology/OSP-Qualification-Reports). The same applies for all presented PBPK models including *evaluation reports* on model building and evaluation of each model (https://github.com/Open-Systems-Pharmacology/OSP-PBPK-Model-Library).

*Evaluation reports* including descriptions on model building and detailed evaluations of the included models are documented separately (see [Section 1.2](#12-CYP3A4-DDI-Network)).

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4 changes: 2 additions & 2 deletions Qualification/Input/Content/Rifampicin-Alfentanil-DDI.md
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The release of the snapshot containing the respective simulations can be found here:
https://github.com/Open-Systems-Pharmacology/Rifampicin-Alfentanil-DDI/releases/tag/v1.0.

The rifampicin / midazolam interaction was evaluated using 5 clinical DDI studies including 16 different clinical settings ([Kharasch 1997](#4-References), [Kharasch 2004](#4-References), [Kharasch 2011](#4-References), [Kharasch 2011b](#4-References), [Phimmasone 2001](#4-References)).
The rifampicin / alfentanil interaction was evaluated using 5 clinical DDI studies including 16 different clinical settings ([Kharasch 1997](#4-References), [Kharasch 2004](#4-References), [Kharasch 2011](#4-References), [Kharasch 2011b](#4-References), [Phimmasone 2001](#4-References)).

| DataID | Enzyme | Perpetrator / victim | Study design | Comment | Clinical study |
| ------ | ------ | ----------------------- | ------------------------------------------------------------ | ------------------------------------------------------------ | ------------------------------- |
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| 763 | CYP3A4 | Rifampicin / alfentanil | Rifampicin: **600** mg po once daily (6 doses)<br />Alfentanil: 1 mg **IV** single dose, **12** h after **5<sup>th</sup>** rifampicin dose | sequential administration of intravenous unlabeled alfentanil and oral deuterated alfentanil | [Kharasch 2011b](#4-References) |
| 771 | CYP3A4 | Rifampicin / alfentanil | Rifampicin: **600** mg po once daily (6 doses)<br />Alfentanil: 4 mg **PO** single dose, **15** h after **5<sup>th</sup>** rifampicin dose | sequential administration of intravenous unlabeled alfentanil and oral deuterated alfentanil | [Kharasch 2011b](#4-References) |
| 767 | CYP3A4 | Rifampicin / alfentanil | Rifampicin: **600** mg po once daily (6 doses)<br />Alfentanil: 1 mg **IV** single dose, **12** h after **6<sup>th</sup>** rifampicin dose | simultaneous administration of intravenous unlabeled alfentanil and oral deuterated alfentanil | [Kharasch 2011b](#4-References) |
| 775 | CYP3A4 | Rifampicin / alfentanil | Rifampicin: **600** mg po once daily (6 doses)<br />Alfentanil: 4 mg **PO** single dose, **12** h after **XX<sup>th</sup>** rifampicin dose | simultaneous administration of intravenous unlabeled alfentanil and oral deuterated alfentanil | [Kharasch 2011b](#4-References) |
| 775 | CYP3A4 | Rifampicin / alfentanil | Rifampicin: **600** mg po once daily (6 doses)<br />Alfentanil: 4 mg **PO** single dose, **12** h after **6<sup>th</sup>** rifampicin dose | simultaneous administration of intravenous unlabeled alfentanil and oral deuterated alfentanil | [Kharasch 2011b](#4-References) |
| 391 | CYP3A4 | Rifampicin / alfentanil | Rifampicin: **600** mg po once daily (5 doses)<br />Alfentanil: 15 µg/kg **IV** single dose, **11** h after **5<sup>th</sup>** rifampicin dose | | [Phimmasone 2001](#4-References) |
2 changes: 1 addition & 1 deletion Qualification/Input/Content/Verapamil-Midazolam-DDI.md
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The release of the snapshot containing the respective simulations can be found here:
https://github.com/Open-Systems-Pharmacology/Verapamil-Midazolam-DDI/releases/tag/v1.0.

The itraconazole / midazolam interaction was evaluated using two clinical DDI studies including 3 different clinical settings ([Backman 1994](#4-References), [Wang 2005](#4-References)).
The verapamil / midazolam interaction was evaluated using two clinical DDI studies including 3 different clinical settings ([Backman 1994](#4-References), [Wang 2005](#4-References)).



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