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Update Qualification Report for DDI_Qualification_CYP2C19#238

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Update Qualification Report for DDI_Qualification_CYP2C19#238
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test-13.0.8-Qualification-DDI-CYP2C19

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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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  • DDI_Qualification_CYP2C19/images/008_section_qualification-of-cyp2c19-mediated-ddi/DDIRatio_1_ddi_ratio_plot_AUC_predictedVsObserved.png is excluded by !**/*.png
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  • DDI_Qualification_CYP2C19/images/008_section_qualification-of-cyp2c19-mediated-ddi/DDIRatio_1_perpetrator_Fluvoxamine_ddi_ratio_plot_AUC_predictedVsObserved.png is excluded by !**/*.png
  • DDI_Qualification_CYP2C19/images/008_section_qualification-of-cyp2c19-mediated-ddi/DDIRatio_1_perpetrator_Fluvoxamine_ddi_ratio_plot_AUC_residualsVsObserved.png is excluded by !**/*.png
  • DDI_Qualification_CYP2C19/images/008_section_qualification-of-cyp2c19-mediated-ddi/DDIRatio_1_perpetrator_Fluvoxamine_ddi_ratio_plot_CMAX_predictedVsObserved.png is excluded by !**/*.png
  • DDI_Qualification_CYP2C19/images/008_section_qualification-of-cyp2c19-mediated-ddi/DDIRatio_1_perpetrator_Fluvoxamine_ddi_ratio_plot_CMAX_residualsVsObserved.png is excluded by !**/*.png
  • DDI_Qualification_CYP2C19/images/008_section_qualification-of-cyp2c19-mediated-ddi/DDIRatio_1_perpetrator_Moclobemide_ddi_ratio_plot_AUC_predictedVsObserved.png is excluded by !**/*.png
  • DDI_Qualification_CYP2C19/images/008_section_qualification-of-cyp2c19-mediated-ddi/DDIRatio_1_perpetrator_Moclobemide_ddi_ratio_plot_AUC_residualsVsObserved.png is excluded by !**/*.png
  • DDI_Qualification_CYP2C19/images/008_section_qualification-of-cyp2c19-mediated-ddi/DDIRatio_1_perpetrator_Omeprazole_ddi_ratio_plot_AUC_predictedVsObserved.png is excluded by !**/*.png
  • DDI_Qualification_CYP2C19/images/008_section_qualification-of-cyp2c19-mediated-ddi/DDIRatio_1_perpetrator_Omeprazole_ddi_ratio_plot_AUC_residualsVsObserved.png is excluded by !**/*.png
  • DDI_Qualification_CYP2C19/images/008_section_qualification-of-cyp2c19-mediated-ddi/DDIRatio_1_victim_Moclobemide__ddi_ratio_plot_AUC_predictedVsObserved.png is excluded by !**/*.png
  • DDI_Qualification_CYP2C19/images/008_section_qualification-of-cyp2c19-mediated-ddi/DDIRatio_1_victim_Moclobemide__ddi_ratio_plot_AUC_residualsVsObserved.png is excluded by !**/*.png
  • DDI_Qualification_CYP2C19/images/008_section_qualification-of-cyp2c19-mediated-ddi/DDIRatio_1_victim_Omeprazole_ddi_ratio_plot_AUC_predictedVsObserved.png is excluded by !**/*.png
  • DDI_Qualification_CYP2C19/images/008_section_qualification-of-cyp2c19-mediated-ddi/DDIRatio_1_victim_Omeprazole_ddi_ratio_plot_AUC_residualsVsObserved.png is excluded by !**/*.png
  • DDI_Qualification_CYP2C19/images/008_section_qualification-of-cyp2c19-mediated-ddi/DDIRatio_1_victim_S_Mephenytoin_ddi_ratio_plot_AUC_predictedVsObserved.png is excluded by !**/*.png
  • DDI_Qualification_CYP2C19/images/008_section_qualification-of-cyp2c19-mediated-ddi/DDIRatio_1_victim_S_Mephenytoin_ddi_ratio_plot_AUC_residualsVsObserved.png is excluded by !**/*.png
  • DDI_Qualification_CYP2C19/images/008_section_qualification-of-cyp2c19-mediated-ddi/DDIRatio_1_victim_S_Mephenytoin_ddi_ratio_plot_CMAX_predictedVsObserved.png is excluded by !**/*.png
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  • DDI_Qualification_CYP2C19/images/009_section_ct-profiles/010_section_omeprazole-moclobemide-ddi/comparison_time_profile_Cho_2002__Omeprazole_40_mg_po__Asian_EM_1.png is excluded by !**/*.png
  • DDI_Qualification_CYP2C19/images/009_section_ct-profiles/010_section_omeprazole-moclobemide-ddi/comparison_time_profile_Cho_2002__Omeprazole_40_mg_po__Asian_PM_2.png is excluded by !**/*.png
  • DDI_Qualification_CYP2C19/images/009_section_ct-profiles/011_section_omeprazole-fluvoxamine-ddi/comparison_time_profile_Yasui_Furukori_2004__Omeprazole_40_mg_po__Asian_EM_3.png is excluded by !**/*.png
  • DDI_Qualification_CYP2C19/images/009_section_ct-profiles/012_section_s-mephenytoin-fluvoxamine-ddi/comparison_time_profile_Yao_2003__S_Mephenytoin_100_mg_po__5.png is excluded by !**/*.png
  • DDI_Qualification_CYP2C19/images/009_section_ct-profiles/013_section_moclobemide-omeprazole-ddi/comparison_time_profile_Yu_2001__Moclobemide_300_mg_po__6.png is excluded by !**/*.png
  • DDI_Qualification_CYP2C19/report.pdf is excluded by !**/*.pdf
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  • DDI_Qualification_CYP2C19/report.md
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Image and PDF Comparison Report

Image Similarity

Similarity Range: 0.9961 - 1.0000

Image Similarity Score
DDI_Qualification_CYP2C19/images/009_section_ct-profiles/012_section_s-mephenytoin-fluvoxamine-ddi/comparison_time_profile_Yao_2003__S_Mephenytoin_100_mg_po__5.png 0.9961
DDI_Qualification_CYP2C19/images/009_section_ct-profiles/013_section_moclobemide-omeprazole-ddi/comparison_time_profile_Yu_2001__Moclobemide_300_mg_po__6.png 0.9976
DDI_Qualification_CYP2C19/images/009_section_ct-profiles/010_section_omeprazole-moclobemide-ddi/comparison_time_profile_Cho_2002__Omeprazole_40_mg_po__Asian_EM_1.png 0.9994
DDI_Qualification_CYP2C19/images/008_section_qualification-of-cyp2c19-mediated-ddi/DDIRatio_1_ddi_ratio_plot_AUC_residualsVsObserved.png 0.9998
DDI_Qualification_CYP2C19/images/008_section_qualification-of-cyp2c19-mediated-ddi/DDIRatio_1_perpetrator_Fluvoxamine_ddi_ratio_plot_CMAX_predictedVsObserved.png 0.9999
DDI_Qualification_CYP2C19/images/008_section_qualification-of-cyp2c19-mediated-ddi/DDIRatio_1_perpetrator_Fluvoxamine_ddi_ratio_plot_AUC_residualsVsObserved.png 0.9999
DDI_Qualification_CYP2C19/images/008_section_qualification-of-cyp2c19-mediated-ddi/DDIRatio_1_victim_S_Mephenytoin_ddi_ratio_plot_CMAX_predictedVsObserved.png 0.9999
DDI_Qualification_CYP2C19/images/008_section_qualification-of-cyp2c19-mediated-ddi/DDIRatio_1_ddi_ratio_plot_AUC_predictedVsObserved.png 0.9999
DDI_Qualification_CYP2C19/images/008_section_qualification-of-cyp2c19-mediated-ddi/DDIRatio_1_victim_S_Mephenytoin_ddi_ratio_plot_AUC_predictedVsObserved.png 0.9999
DDI_Qualification_CYP2C19/images/008_section_qualification-of-cyp2c19-mediated-ddi/DDIRatio_1_victim_S_Mephenytoin_ddi_ratio_plot_AUC_residualsVsObserved.png 0.9999
DDI_Qualification_CYP2C19/images/009_section_ct-profiles/011_section_omeprazole-fluvoxamine-ddi/comparison_time_profile_Yasui_Furukori_2004__Omeprazole_40_mg_po__Asian_EM_3.png 0.9999
DDI_Qualification_CYP2C19/images/008_section_qualification-of-cyp2c19-mediated-ddi/DDIRatio_1_perpetrator_Fluvoxamine_ddi_ratio_plot_AUC_predictedVsObserved.png 0.9999
DDI_Qualification_CYP2C19/images/008_section_qualification-of-cyp2c19-mediated-ddi/DDIRatio_1_ddi_ratio_plot_CMAX_residualsVsObserved.png 0.9999
DDI_Qualification_CYP2C19/images/008_section_qualification-of-cyp2c19-mediated-ddi/DDIRatio_1_perpetrator_Fluvoxamine_ddi_ratio_plot_CMAX_residualsVsObserved.png 0.9999
DDI_Qualification_CYP2C19/images/008_section_qualification-of-cyp2c19-mediated-ddi/DDIRatio_1_victim_S_Mephenytoin_ddi_ratio_plot_CMAX_residualsVsObserved.png 0.9999
DDI_Qualification_CYP2C19/images/008_section_qualification-of-cyp2c19-mediated-ddi/DDIRatio_1_victim_Omeprazole_ddi_ratio_plot_AUC_residualsVsObserved.png 1.0000
DDI_Qualification_CYP2C19/images/008_section_qualification-of-cyp2c19-mediated-ddi/DDIRatio_1_victim_Omeprazole_ddi_ratio_plot_AUC_predictedVsObserved.png 1.0000
DDI_Qualification_CYP2C19/images/008_section_qualification-of-cyp2c19-mediated-ddi/DDIRatio_1_perpetrator_Moclobemide_ddi_ratio_plot_AUC_predictedVsObserved.png 1.0000
DDI_Qualification_CYP2C19/images/008_section_qualification-of-cyp2c19-mediated-ddi/DDIRatio_1_ddi_ratio_plot_CMAX_predictedVsObserved.png 1.0000
DDI_Qualification_CYP2C19/images/008_section_qualification-of-cyp2c19-mediated-ddi/DDIRatio_1_perpetrator_Omeprazole_ddi_ratio_plot_AUC_predictedVsObserved.png 1.0000
DDI_Qualification_CYP2C19/images/008_section_qualification-of-cyp2c19-mediated-ddi/DDIRatio_1_victim_Moclobemide__ddi_ratio_plot_AUC_predictedVsObserved.png 1.0000
DDI_Qualification_CYP2C19/images/008_section_qualification-of-cyp2c19-mediated-ddi/DDIRatio_1_perpetrator_Moclobemide_ddi_ratio_plot_AUC_residualsVsObserved.png 1.0000
DDI_Qualification_CYP2C19/images/008_section_qualification-of-cyp2c19-mediated-ddi/DDIRatio_1_perpetrator_Omeprazole_ddi_ratio_plot_AUC_residualsVsObserved.png 1.0000
DDI_Qualification_CYP2C19/images/008_section_qualification-of-cyp2c19-mediated-ddi/DDIRatio_1_victim_Moclobemide__ddi_ratio_plot_AUC_residualsVsObserved.png 1.0000
DDI_Qualification_CYP2C19/images/009_section_ct-profiles/010_section_omeprazole-moclobemide-ddi/comparison_time_profile_Cho_2002__Omeprazole_40_mg_po__Asian_PM_2.png 1.0000

PDF Text Comparison

DDI_Qualification_CYP2C19/report.pdf

Text Differences (click to expand)
--- a/DDI_Qualification_CYP2C19/report.pdf
+++ b/DDI_Qualification_CYP2C19/report.pdf
@@ -1,7 +1,7 @@
 CYP2C19 DDI Qualification

-Version 2.0-OSP12.3

+Version 2.0-OSP13.0

 Qualification Plan Release https://github.com/Open-Systems-Pharmacology/Qualification-DDI-CYP2C19/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

@@ -253,17 +253,17 @@
 2004

 S-

 Fluvoxamine,

-15001 Mephenytoin, 3.85 4.64 0.83 2.14 2.12 1.01 Yao 2003

+15001 Mephenytoin, 3.85 4.64 0.83 2.13 2.12 1.01 Yao 2003

 27.5 mg, PO,

 PO

 S-

 Fluvoxamine,

-15002 Mephenytoin, 6.33 6.70 0.95 2.49 2.40 1.04 Yao 2003

+15002 Mephenytoin, 6.35 6.70 0.95 2.49 2.40 1.04 Yao 2003

 45.8 mg, PO,

 PO

 S-

 Fluvoxamine,

-15003 Mephenytoin, 8.07 9.89 0.82 2.63 2.42 1.09 Yao 2003

+15003 Mephenytoin, 8.10 9.89 0.82 2.63 2.42 1.09 Yao 2003

 64.1 mg, PO,

 PO

 2.1 Perpetrator

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