Update Qualification Report for DDI_Qualification_UGT

[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

Summary by CodeRabbit

• Documentation
  • Updated the report version from OSP12.3 to OSP13.0.
  • Corrected predicted and predicted-to-observed exposure ratios for DataID 642 in the UGT inhibition DDI table.

[coderabbitai]

No actionable comments were generated in the recent review. 🎉

ℹ️ Recent review info

⚙️ Run configuration

Configuration used: Organization UI

Review profile: CHILL

Plan: Pro

Run ID: 1d1fd380-5bdd-4fa1-a457-836034cbbd0c

📥 Commits

Reviewing files that changed from the base of the PR and between 3688dc0 and 1eac98f.

⛔ Files ignored due to path filters (9)

• DDI_Qualification_UGT/images/006_section_qualification-of-ugt-mediated-ddi/DDIRatio_1_ddi_ratio_plot_AUC_predictedVsObserved.png is excluded by !**/*.png
• DDI_Qualification_UGT/images/006_section_qualification-of-ugt-mediated-ddi/DDIRatio_1_ddi_ratio_plot_AUC_residualsVsObserved.png is excluded by !**/*.png
• DDI_Qualification_UGT/images/006_section_qualification-of-ugt-mediated-ddi/DDIRatio_1_ddi_ratio_plot_CMAX_predictedVsObserved.png is excluded by !**/*.png
• DDI_Qualification_UGT/images/006_section_qualification-of-ugt-mediated-ddi/DDIRatio_1_ddi_ratio_plot_CMAX_residualsVsObserved.png is excluded by !**/*.png
• DDI_Qualification_UGT/images/007_section_ct-profiles/008_section_atazanavir-raltegravir-ddi/comparison_time_profile_Krishna_2016_2.png is excluded by !**/*.png
• DDI_Qualification_UGT/images/007_section_ct-profiles/008_section_atazanavir-raltegravir-ddi/comparison_time_profile_Neely_2010_3.png is excluded by !**/*.png
• DDI_Qualification_UGT/images/007_section_ct-profiles/008_section_atazanavir-raltegravir-ddi/comparison_time_profile_Zhu_2010_4.png is excluded by !**/*.png
• DDI_Qualification_UGT/images/007_section_ct-profiles/009_section_mefenamic-acid-dapagliflozin-ddi/comparison_time_profile_Kasichayanula_2013a_5.png is excluded by !**/*.png
• DDI_Qualification_UGT/report.pdf is excluded by !**/*.pdf

📒 Files selected for processing (1)

• DDI_Qualification_UGT/report.md

---

📝 Walkthrough

Walkthrough

The UGT qualification report was updated from OSP12.3 to OSP13.0, and three predicted-to-observed ratio values for DataID 642 were adjusted.

Changes

UGT qualification report update

Layer / File(s)	Summary
Update report metadata and table values DDI_Qualification_UGT/report.md	The header version changed to 2.0-OSP13.0, and the DataID 642 ratio values in Table 2-4 were increased.

Estimated code review effort: 1 (Trivial) | ~2 minutes

Possibly related PRs

• Open-Systems-Pharmacology/OSP-Qualification-Reports#169: Updates the same report’s OSP metadata and UGT table values.
• Open-Systems-Pharmacology/OSP-Qualification-Reports#188: Updates OSP version metadata in the same report.
• Open-Systems-Pharmacology/OSP-Qualification-Reports#233: Applies the same OSP12.3-to-OSP13.0 header update pattern.

Suggested reviewers: yuri05

Poem

I’m a rabbit with a report to renew,
OSP13.0 now shines through.
Three tiny ratios took a hop,
DataID 642 reached the top.
One neat update—thump, thump, hooray!

🚥 Pre-merge checks | ✅ 4

✅ Passed checks (4 passed)

Check name	Status	Explanation
Description Check	✅ Passed	Check skipped - CodeRabbit’s high-level summary is enabled.
Title check	✅ Passed	The title clearly matches the main change: updating the DDI_Qualification_UGT qualification report.
Linked Issues check	✅ Passed	Check skipped because no linked issues were found for this pull request.
Out of Scope Changes check	✅ Passed	Check skipped because no linked issues were found for this pull request.

✨ Finishing Touches

🧪 Generate unit tests (beta)

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

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Image and PDF Comparison Report

Image Similarity

Similarity Range: 0.9958 - 0.9999

Image	Similarity Score
DDI_Qualification_UGT/images/007_section_ct-profiles/008_section_atazanavir-raltegravir-ddi/comparison_time_profile_Neely_2010_3.png	0.9958
DDI_Qualification_UGT/images/007_section_ct-profiles/009_section_mefenamic-acid-dapagliflozin-ddi/comparison_time_profile_Kasichayanula_2013a_5.png	0.9972
DDI_Qualification_UGT/images/007_section_ct-profiles/008_section_atazanavir-raltegravir-ddi/comparison_time_profile_Zhu_2010_4.png	0.9982
DDI_Qualification_UGT/images/007_section_ct-profiles/008_section_atazanavir-raltegravir-ddi/comparison_time_profile_Krishna_2016_2.png	0.9989
DDI_Qualification_UGT/images/006_section_qualification-of-ugt-mediated-ddi/DDIRatio_1_ddi_ratio_plot_CMAX_predictedVsObserved.png	0.9998
DDI_Qualification_UGT/images/006_section_qualification-of-ugt-mediated-ddi/DDIRatio_1_ddi_ratio_plot_AUC_predictedVsObserved.png	0.9998
DDI_Qualification_UGT/images/006_section_qualification-of-ugt-mediated-ddi/DDIRatio_1_ddi_ratio_plot_AUC_residualsVsObserved.png	0.9999
DDI_Qualification_UGT/images/006_section_qualification-of-ugt-mediated-ddi/DDIRatio_1_ddi_ratio_plot_CMAX_residualsVsObserved.png	0.9999

PDF Text Comparison

DDI_Qualification_UGT/report.pdf

Text Differences (click to expand)

--- a/DDI_Qualification_UGT/report.pdf
+++ b/DDI_Qualification_UGT/report.pdf
@@ -1,7 +1,7 @@
 UGT DDI Inhibition Qualification

-Version 2.0-OSP12.3

+Version 2.0-OSP13.0

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

@@ -176,7 +176,7 @@
 250 mg,

 PO, MD

 Dapagliflozin, Kasichayanula

-642 QID (4 1.41 1.51 0.93 1.16 1.13 1.02

+642 QID (4 1.42 1.51 0.94 1.16 1.13 1.03

 PO 2013a

 days), with

 first dose