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OSP-Qualification-Reports created with OSP 9.1
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Yuri05 authored Jul 22, 2020
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22 changes: 11 additions & 11 deletions DDI_Qualification_CYP3A4/report.md
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| Version | 1.0-OSP9.0 |
| Version | 1.0-OSP9.1 |
| ------------------------------- | ------------------------------------------------------------ |
| Qualification Plan Release | https://github.com/Open-Systems-Pharmacology/Qualification-DDI-CYP3A4/releases/tag/v1.0 |
| OSP Version | 9.0 |
| OSP Version | 9.1 |
| Qualification Framework Version | 2.2 |


Expand Down Expand Up @@ -531,9 +531,9 @@ In the plots,

![004_plotDDIRatioCMAXResidualsVsObserved.png](images/002_2_Qualification_of_Use_Case_CYP3A4-mediated_DDI/004_plotDDIRatioCMAXResidualsVsObserved.png)

GMFE (AUC) = 1.398725
GMFE (AUC) = 1.398739

GMFE (CMAX) = 1.370608
GMFE (CMAX) = 1.370621

|AUC |Number|Ratio [%]|
|-------------------------:|-----:|--------:|
Expand All @@ -557,7 +557,7 @@ GMFE (CMAX) = 1.370608
|354 |Clarithromycin, 500 mg, PO, MD BID (4 days) |Midazolam, PO |5.871 |5.5556 |1.0568 |2.6201 |- |- |Markert 2013 |
|1099 |Clarithromycin, 500 mg, PO, MD BID (5 days) |Midazolam, PO |7.8476 |4.84 |1.6214 |3.177 |2.69 |1.181 |Prueksaritanont 2017|
|2030 |Clarithromycin, 500 mg, PO, MD BID (7 days) |Midazolam, PO |9.0373 |8 |1.1297 |3.1442 |2.75 |1.1433 |Quinney 2008 |
|2004 |Clarithromycin, 250 mg, PO, MD BID (3 days) |Midazolam, PO |1.4921 |1.9 |0.78531 |1.258 |1.75 |0.71885 |van Dyk 2018 |
|2004 |Clarithromycin, 250 mg, PO, MD BID (3 days) |Midazolam, PO |1.4904 |1.9 |0.78442 |1.2571 |1.75 |0.71833 |van Dyk 2018 |
|469 |Clarithromycin, 250 mg, PO, MD BID (5 days) |Midazolam, PO |2.3757 |3.5716 |0.66518 |1.5939 |2.44 |0.65325 |Yeates 1996 |
|1102 |Clarithromycin, 500 mg, PO, MD OD (2 days) |Triazolam, PO |3.5766 |5.06 |0.70684 |2.0063 |1.968 |1.0194 |Greenblatt 1998a |
|779 |Erythromycin, 500 mg, PO, SD |Alfentanil, IV|1.0294 |1.0262 |1.0031 |1 |- |- |Bartkowski 1989 |
Expand Down Expand Up @@ -732,9 +732,9 @@ GMFE (CMAX) = 1.451894

![004_plotDDIRatioCMAXResidualsVsObserved.png](images/002_2_Qualification_of_Use_Case_CYP3A4-mediated_DDI/001_Mechanism/003_Mechanism_based_Inactivation/004_plotDDIRatioCMAXResidualsVsObserved.png)

GMFE (AUC) = 1.271545
GMFE (AUC) = 1.271597

GMFE (CMAX) = 1.240603
GMFE (CMAX) = 1.240656

|AUC |Number|Ratio [%]|
|-------------------------:|-----:|--------:|
Expand All @@ -760,9 +760,9 @@ GMFE (CMAX) = 1.240603

![004_plotDDIRatioCMAXResidualsVsObserved.png](images/002_2_Qualification_of_Use_Case_CYP3A4-mediated_DDI/002_Perpetrator/001_Clarithromycin/004_plotDDIRatioCMAXResidualsVsObserved.png)

GMFE (AUC) = 1.257076
GMFE (AUC) = 1.257206

GMFE (CMAX) = 1.235171
GMFE (CMAX) = 1.235284

|AUC |Number|Ratio [%]|
|-------------------------:|-----:|--------:|
Expand Down Expand Up @@ -996,9 +996,9 @@ GMFE (CMAX) = 1.242657

![004_plotDDIRatioCMAXResidualsVsObserved.png](images/002_2_Qualification_of_Use_Case_CYP3A4-mediated_DDI/003_Victim/003_Midazolam/004_plotDDIRatioCMAXResidualsVsObserved.png)

GMFE (AUC) = 1.413926
GMFE (AUC) = 1.413945

GMFE (CMAX) = 1.432132
GMFE (CMAX) = 1.432152

|AUC |Number|Ratio [%]|
|-------------------------:|-----:|--------:|
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4 changes: 2 additions & 2 deletions DDI_Qualification_UGT/report.md
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| Version | 1.1-OSP9.0 |
| Version | 1.1-OSP9.1 |
| ------------------------------- | ------------------------------------------------------------ |
| Qualification Plan Release | https://github.com/Open-Systems-Pharmacology/Qualification-DDI-UGT/releases/tag/v1.1 |
| OSP Version | 9.0 |
| OSP Version | 9.1 |
| Qualification Framework Version | 2.2 |


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4 changes: 2 additions & 2 deletions Pediatric_Qualification_Package_CYP2C8_Ontogeny/report.md
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| Version | 1.1-OSP9.0 |
| Version | 1.1-OSP9.1 |
| ------------------------------- | ------------------------------------------------------------ |
| Qualification Plan Release | https://github.com/Open-Systems-Pharmacology/Pediatric_Qualification_Package_CYP2C8_Ontogeny/releases/tag/v1.1 |
| OSP Version | 9.0 |
| OSP Version | 9.1 |
| Qualification Framework Version | 2.2 |


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30 changes: 24 additions & 6 deletions Pediatric_Qualification_Package_CYP3A4_Ontogeny/report.md
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| Version | 1.1-OSP9.0 |
| Version | 1.2-OSP9.1 |
| ------------------------------- | ------------------------------------------------------------ |
| Qualification Plan Release | https://github.com/Open-Systems-Pharmacology/Pediatric_Qualification_Package_CYP3A4_Ontogeny/releases/tag/v1.1 |
| OSP Version | 9.0 |
| Qualification Plan Release | https://github.com/Open-Systems-Pharmacology/Pediatric_Qualification_Package_CYP3A4_Ontogeny/releases/tag/v1.2 |
| OSP Version | 9.1 |
| Qualification Framework Version | 2.2 |


Expand Down Expand Up @@ -73,7 +73,6 @@ To qualify the OSP suite for the pediatric translation of the pharmacokinetics o
[4] [Alfentanil-Model, Whole-body PBPK model of Alfentanil. https://github.com/Open-Systems-Pharmacology/Alfentanil-Model](https://github.com/incei/Alfentanil-Model)

[5] [Sufentanil-Model, Whole-body PBPK model of Sufentanil. https://github.com/Open-Systems-Pharmacology/Sufentanil-Model](https://github.com/incei/Sufentanil-Model)

# Chapter 2: Pediatric translation qualification results
## Evaluation of Pediatric translation

Expand All @@ -90,8 +89,7 @@ The ratios of predicted over observed mean AUC or CL values from all compound we
In the next sections the demographics as well as the evaluation results of the predictive performance of the specific compound PBPK models in children can be found.



![001_plotPKRatioAUC.png](images/001_Chapter_1__Introduction_to_Pediatric_Translation_and_CYP3A4_Ontogeny_Qualification/001_plotPKRatioAUC.png)
![005_plotPKRatioAUC.png](images/002_Chapter_2__Pediatric_translation_qualification_results/005_plotPKRatioAUC.png)

GMFE (AUC) = 1.254230

Expand Down Expand Up @@ -323,10 +321,30 @@ Intrinsic clearance | 9.6138746106 l/min | Parameter Identification-Parameter Id
Below you find the input goodness-of-fit visual diagnostic plots for sufentanil PBPK model performance (observed versus individually simulated plasma concentration and weighted residuals versus time) of all adult data.


![001_plotGOFMergedPredictedVsObserved.png](images/003_Chapter_3__Adult_PBPK_model_building_and_performance/002_Chapter_3_2__Sufentanil_Diagnostics_Plots/001_plotGOFMergedPredictedVsObserved.png)

GMFE = 1.402222

![003_plotGOFMergedResidualsOverTime.png](images/003_Chapter_3__Adult_PBPK_model_building_and_performance/002_Chapter_3_2__Sufentanil_Diagnostics_Plots/003_plotGOFMergedResidualsOverTime.png)

GMFE = 1.402222

## Chapter 3.3: Sufentanil Concentration-Time profiles in Adults
#### Concentration-Time Profiles

Simulated versus observed plasma concentration-time profiles of all data are listed below.
![001_plotTimeProfile.png](images/003_Chapter_3__Adult_PBPK_model_building_and_performance/003_Chapter_3_3__Sufentanil_Concentration-Time_profiles_in_Adults/001_plotTimeProfile.png)

![002_plotTimeProfile.png](images/003_Chapter_3__Adult_PBPK_model_building_and_performance/003_Chapter_3_3__Sufentanil_Concentration-Time_profiles_in_Adults/002_plotTimeProfile.png)

![003_plotTimeProfile.png](images/003_Chapter_3__Adult_PBPK_model_building_and_performance/003_Chapter_3_3__Sufentanil_Concentration-Time_profiles_in_Adults/003_plotTimeProfile.png)

![004_plotTimeProfile.png](images/003_Chapter_3__Adult_PBPK_model_building_and_performance/003_Chapter_3_3__Sufentanil_Concentration-Time_profiles_in_Adults/004_plotTimeProfile.png)

![005_plotTimeProfile.png](images/003_Chapter_3__Adult_PBPK_model_building_and_performance/003_Chapter_3_3__Sufentanil_Concentration-Time_profiles_in_Adults/005_plotTimeProfile.png)

![006_plotTimeProfile.png](images/003_Chapter_3__Adult_PBPK_model_building_and_performance/003_Chapter_3_3__Sufentanil_Concentration-Time_profiles_in_Adults/006_plotTimeProfile.png)

## Chapter 3.4: Alfentanil Input Tables
### Alfentanil model

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4 changes: 2 additions & 2 deletions Pediatric_Qualification_Package_GFR_Ontogeny/report.md
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| Version | 1.1-OSP9.0 |
| Version | 1.1-OSP9.1 |
| ------------------------------- | ------------------------------------------------------------ |
| Qualification Plan Release | https://github.com/Open-Systems-Pharmacology/Pediatric_Qualification_Package_GFR_Ontogeny/releases/tag/v1.1 |
| OSP Version | 9.0 |
| OSP Version | 9.1 |
| Qualification Framework Version | 2.2 |


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