Update Qualification Report for DDI_Qualification_CYP1A2

[osp-reports-creator]

Tools

Tool	Version	Url
R	4.5.2	NA
ospsuite-R	v13	NA
Reporting Engine	2.4.7	NA
RUtils	1.11.1	NA
TLF	1.6.2	NA
rClr	NA	NA
rSharp	V13	NA
Qualification Runner	13.0.3	https://github.com/Yuri05/Test20/releases/download/Test13_01/QualificationRunner-13.0.3.zip
Qualification Framework	3.7	NA
PK-Sim	13.0.8	https://github.com/Yuri05/Test20/releases/download/Test13_01/PKSimPortable_13.0.8.zip

Qualification plans

Execute	Repository name	Released version	Workflow name	Folder name
true	Qualification-DDI-CYP1A2	2.0		DDI_Qualification_CYP1A2
true	Qualification-DDI-CYP2C19	2.0		DDI_Qualification_CYP2C19
true	Qualification-DDI-CYP3A4	2.2		DDI_Qualification_CYP3A4
true	Qualification-DDI-P-gp	1.2		DDI_Qualification_P-gp
true	Qualification-DDI-UGT	2.0		DDI_Qualification_UGT
true	Pediatric_Qualification_Package_CYP2C8_Ontogeny	2.0		Pediatric_Qualification_Package_CYP2C8_Ontogeny
true	Pediatric_Qualification_Package_CYP3A4_Ontogeny	2.0		Pediatric_Qualification_Package_CYP3A4_Ontogeny
true	Pediatric_Qualification_Package_GFR_Ontogeny	2.0		Pediatric_Qualification_Package_GFR_Ontogeny
true	Qualification-CKD	1.1		Qualification-CKD
true	Pediatric_Qualification_Package_P-gp_Ontogeny	1.0		Pediatric_P-gp

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⛔ Files ignored due to path filters (22)

• DDI_Qualification_CYP1A2/images/011_section_qualification-cyp1a2-ddi/DDIRatio_1_ddi_ratio_plot_AUC_predictedVsObserved.png is excluded by !**/*.png
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• DDI_Qualification_CYP1A2/images/011_section_qualification-cyp1a2-ddi/DDIRatio_1_ddi_ratio_plot_CMAX_predictedVsObserved.png is excluded by !**/*.png
• DDI_Qualification_CYP1A2/images/011_section_qualification-cyp1a2-ddi/DDIRatio_1_ddi_ratio_plot_CMAX_residualsVsObserved.png is excluded by !**/*.png
• DDI_Qualification_CYP1A2/images/011_section_qualification-cyp1a2-ddi/DDIRatio_1_perpetrator_Ethinylestradiol_ddi_ratio_plot_CMAX_predictedVsObserved.png is excluded by !**/*.png
• DDI_Qualification_CYP1A2/images/011_section_qualification-cyp1a2-ddi/DDIRatio_1_perpetrator_Fluvoxamine_ddi_ratio_plot_AUC_predictedVsObserved.png is excluded by !**/*.png
• DDI_Qualification_CYP1A2/images/011_section_qualification-cyp1a2-ddi/DDIRatio_1_perpetrator_Fluvoxamine_ddi_ratio_plot_AUC_residualsVsObserved.png is excluded by !**/*.png
• DDI_Qualification_CYP1A2/images/011_section_qualification-cyp1a2-ddi/DDIRatio_1_perpetrator_Fluvoxamine_ddi_ratio_plot_CMAX_predictedVsObserved.png is excluded by !**/*.png
• DDI_Qualification_CYP1A2/images/011_section_qualification-cyp1a2-ddi/DDIRatio_1_perpetrator_Fluvoxamine_ddi_ratio_plot_CMAX_residualsVsObserved.png is excluded by !**/*.png
• DDI_Qualification_CYP1A2/images/011_section_qualification-cyp1a2-ddi/DDIRatio_1_victim_Caffeine_ddi_ratio_plot_AUC_predictedVsObserved.png is excluded by !**/*.png
• DDI_Qualification_CYP1A2/images/011_section_qualification-cyp1a2-ddi/DDIRatio_1_victim_Caffeine_ddi_ratio_plot_AUC_residualsVsObserved.png is excluded by !**/*.png
• DDI_Qualification_CYP1A2/images/011_section_qualification-cyp1a2-ddi/DDIRatio_1_victim_Caffeine_ddi_ratio_plot_CMAX_predictedVsObserved.png is excluded by !**/*.png
• DDI_Qualification_CYP1A2/images/011_section_qualification-cyp1a2-ddi/DDIRatio_1_victim_Caffeine_ddi_ratio_plot_CMAX_residualsVsObserved.png is excluded by !**/*.png
• DDI_Qualification_CYP1A2/images/011_section_qualification-cyp1a2-ddi/DDIRatio_1_victim_Tizanidine_ddi_ratio_plot_AUC_predictedVsObserved.png is excluded by !**/*.png
• DDI_Qualification_CYP1A2/images/011_section_qualification-cyp1a2-ddi/DDIRatio_1_victim_Tizanidine_ddi_ratio_plot_AUC_residualsVsObserved.png is excluded by !**/*.png
• DDI_Qualification_CYP1A2/images/011_section_qualification-cyp1a2-ddi/DDIRatio_1_victim_Tizanidine_ddi_ratio_plot_CMAX_predictedVsObserved.png is excluded by !**/*.png
• DDI_Qualification_CYP1A2/images/011_section_qualification-cyp1a2-ddi/DDIRatio_1_victim_Tizanidine_ddi_ratio_plot_CMAX_residualsVsObserved.png is excluded by !**/*.png
• DDI_Qualification_CYP1A2/images/012_section_ct-profiles/014_section_ct-profiles-caffeine-fluvoxamine-ddi/comparison_time_profile_Culm_Merdeck_2005__Caffeine_250_mg_po__3.png is excluded by !**/*.png
• DDI_Qualification_CYP1A2/images/012_section_ct-profiles/014_section_ct-profiles-caffeine-fluvoxamine-ddi/comparison_time_profile_Jeppesen_1996__Caffeine_200_mg_po__2.png is excluded by !**/*.png
• DDI_Qualification_CYP1A2/images/012_section_ct-profiles/015_section_ct-profiles-tizanidine-fluvoxamine-ddi/comparison_time_profile_Granfors_2004__Tizanidine_4_mg_po__4.png is excluded by !**/*.png
• DDI_Qualification_CYP1A2/images/012_section_ct-profiles/017_section_ct-profiles-caffeine-mexiletine-ddi/comparison_time_profile_Joeres_1987__Caffeine_336_mg_po__6.png is excluded by !**/*.png
• DDI_Qualification_CYP1A2/report.pdf is excluded by !**/*.pdf

📒 Files selected for processing (1)

• DDI_Qualification_CYP1A2/report.md

✨ Finishing Touches

🧪 Generate unit tests (beta)

• Create PR with unit tests
• Commit unit tests in branch test-13.0.8-Qualification-DDI-CYP1A2

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Image and PDF Comparison Report

Image Similarity

Similarity Range: 0.9424 - 1.0000

Image	Similarity Score
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DDI_Qualification_CYP1A2/images/011_section_qualification-cyp1a2-ddi/DDIRatio_1_ddi_ratio_plot_AUC_predictedVsObserved.png	0.9429
DDI_Qualification_CYP1A2/images/011_section_qualification-cyp1a2-ddi/DDIRatio_1_victim_Tizanidine_ddi_ratio_plot_AUC_predictedVsObserved.png	0.9432
DDI_Qualification_CYP1A2/images/011_section_qualification-cyp1a2-ddi/DDIRatio_1_perpetrator_Fluvoxamine_ddi_ratio_plot_CMAX_predictedVsObserved.png	0.9659
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DDI_Qualification_CYP1A2/images/012_section_ct-profiles/014_section_ct-profiles-caffeine-fluvoxamine-ddi/comparison_time_profile_Jeppesen_1996__Caffeine_200_mg_po__2.png	0.9974
DDI_Qualification_CYP1A2/images/012_section_ct-profiles/015_section_ct-profiles-tizanidine-fluvoxamine-ddi/comparison_time_profile_Granfors_2004__Tizanidine_4_mg_po__4.png	0.9974
DDI_Qualification_CYP1A2/images/012_section_ct-profiles/014_section_ct-profiles-caffeine-fluvoxamine-ddi/comparison_time_profile_Culm_Merdeck_2005__Caffeine_250_mg_po__3.png	0.9978
DDI_Qualification_CYP1A2/images/012_section_ct-profiles/017_section_ct-profiles-caffeine-mexiletine-ddi/comparison_time_profile_Joeres_1987__Caffeine_336_mg_po__6.png	0.9983
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PDF Text Comparison

DDI_Qualification_CYP1A2/report.pdf

Text Differences (click to expand)

--- a/DDI_Qualification_CYP1A2/report.pdf
+++ b/DDI_Qualification_CYP1A2/report.pdf
@@ -1,7 +1,7 @@
 CYP1A2 DDI Qualification

-Version 2.0-OSP12.3

+Version 2.0-OSP13.0

 Qualification Plan Release https://github.com/Open-Systems-Pharmacology/Qualification-DDI-CYP1A2/releases/tag/v2.0

-OSP Version 12.3

+OSP Version 13.0

 Qualification Framework Version 3.7

 This qualification report is filed at:

 https://github.com/Open-Systems-Pharmacology/OSP-Qualification-Reports

@@ -280,7 +280,7 @@
 6110 5.84 2.13 2.74 1.10 1.15 0.96

 0.03 mg, PO, PO 1995

 Fluvoxamine, Tizanidine, Granfors

-13017 39.12 33.00 1.19 16.00 12.10 1.32

+13017 38.77 33.00 1.17 15.95 12.10 1.32

 100 mg, PO, PO 2004

 Mexiletine, 50 Tizanidine, Momo

 13018 2.48 3.42 0.73 2.42 3.22 0.75

@@ -289,11 +289,11 @@
 14002 4.41 3.92 1.13 3.75 3.02 1.24

 20 mg, PO, PO 2005

 Fluvoxamine, Caffeine, Jeppesen

-14004 9.97 7.16 1.39 1.08 1.09 0.99

+14004 10.02 7.16 1.40 1.08 1.09 0.99

 100 mg, PO, PO 1996

 Culm-

 Fluvoxamine, Caffeine,

-14006 13.64 13.71 0.99 1.34 1.40 0.96 Merdek

+14006 13.65 13.71 1.00 1.34 1.40 0.96 Merdek

 100 mg, PO, PO

 2005

 Mexiletine, 200 Caffeine, Joeres

@@ -427,7 +427,7 @@
 et al. formula)

 Table 2-17: GMFE for CYP1A2 DDI Ratio

 PK parameter GMFE

-AUC 1.19

+AUC 1.18

 CMAX 1.07

 Table 2-18: Summary table for CYP1A2 DDI - AUC Ratio. (δ = 1 in Guest et al. formula)

 AUC Number Ratio [%]

@@ -454,7 +454,7 @@
 et al. formula)

 Table 2-20: GMFE for CYP1A2 DDI Ratio

 PK parameter GMFE

-AUC 1.23

+AUC 1.22

 CMAX 1.30

 Table 2-21: Summary table for CYP1A2 DDI - AUC Ratio. (δ = 1 in Guest et al. formula)

 AUC Number Ratio [%]