Update Qualification Report for DDI_Qualification_P-gp by osp-reports-creator · Pull Request #244 · Open-Systems-Pharmacology/OSP-Qualification-Reports

osp-reports-creator · 2026-07-14T17:42:37Z

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	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 qualification report to reflect OSP version 13.0.
- Revised reported quality metrics and study-level AUCR/Cmax ratio results across multiple qualification scenarios.

coderabbitai · 2026-07-14T17:42:56Z

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: c95dc634-732e-4146-be76-a0a75483645a

📥 Commits

Reviewing files that changed from the base of the PR and between 3688dc0 and dd3f1ad.

⛔ Files ignored due to path filters (61)

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📒 Files selected for processing (1)

DDI_Qualification_P-gp/report.md

📝 Walkthrough

Walkthrough

Updated the P-gp qualification report from OSP 12.3 to OSP 13.0, including qualification metadata, GMFE results, and study-level AUCR/Cmax ratio values.

Changes

P-gp qualification report

Layer / File(s)	Summary
Qualification version metadata `DDI_Qualification_P-gp/report.md`	Updates the qualification and OSP version fields from 12.3 to 13.0.
Qualification metrics and study results `DDI_Qualification_P-gp/report.md`	Revises overall, mechanism-specific, perpetrator-specific, and victim-specific GMFE values, along with detailed study-level AUCR and Cmax ratios.

Estimated code review effort: 2 (Simple) | ~10 minutes

Possibly related PRs

Open-Systems-Pharmacology/OSP-Qualification-Reports#169: Updates version metadata in the same P-gp report.
Open-Systems-Pharmacology/OSP-Qualification-Reports#229: Modifies overlapping metadata and qualification metrics in the same report.
Open-Systems-Pharmacology/OSP-Qualification-Reports#234: Updates the P-gp qualification report for the OSP 12.3 to 13.0 plan change.

Suggested reviewers: yuri05

Poem

A rabbit checks each number twice,
As OSP blooms to version thirteen’s light.
GMFEs hop and ratios align,
New study values neatly shine.
The P-gp report is fresh and bright!

🚥 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 and concisely describes the main change: updating the DDI_Qualification_P-gp 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-P-gp

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github-actions · 2026-07-14T17:44:16Z

Image and PDF Comparison Report

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DDI_Qualification_P-gp/images/010_section_concentration-time-profiles/015_section_rifampicin-digoxin-ddi-timeprofile/comparison_time_profile_Gurley_2007_29.png	0.9991
DDI_Qualification_P-gp/images/009_section_qualification-of-use-case-pgp-mediated-ddi/DDIRatio_1_mechanism_Reversible_Inhibition_ddi_ratio_plot_C_max_residualsVsObserved.png	0.9992
DDI_Qualification_P-gp/images/010_section_concentration-time-profiles/015_section_rifampicin-digoxin-ddi-timeprofile/comparison_time_profile_Gurley_2006_28.png	0.9992
DDI_Qualification_P-gp/images/009_section_qualification-of-use-case-pgp-mediated-ddi/DDIRatio_1_mechanism_Reversible_Inhibition_ddi_ratio_plot_C_max_predictedVsObserved.png	0.9992
DDI_Qualification_P-gp/images/009_section_qualification-of-use-case-pgp-mediated-ddi/DDIRatio_1_mechanism_Induction_ddi_ratio_plot_AUC_tEnd_residualsVsObserved.png	0.9994
DDI_Qualification_P-gp/images/009_section_qualification-of-use-case-pgp-mediated-ddi/DDIRatio_1_perpetrator_Rifampicin_ddi_ratio_plot_AUC_tEnd_residualsVsObserved.png	0.9994
DDI_Qualification_P-gp/images/009_section_qualification-of-use-case-pgp-mediated-ddi/DDIRatio_1_mechanism_Induction_ddi_ratio_plot_AUC_tEnd_predictedVsObserved.png	0.9994
DDI_Qualification_P-gp/images/009_section_qualification-of-use-case-pgp-mediated-ddi/DDIRatio_1_perpetrator_Rifampicin_ddi_ratio_plot_AUC_tEnd_predictedVsObserved.png	0.9994
DDI_Qualification_P-gp/images/009_section_qualification-of-use-case-pgp-mediated-ddi/DDIRatio_1_perpetrator_Clarithromycin_ddi_ratio_plot_C_max_residualsVsObserved.png	0.9994
DDI_Qualification_P-gp/images/009_section_qualification-of-use-case-pgp-mediated-ddi/DDIRatio_1_perpetrator_Itraconazole_ddi_ratio_plot_C_max_predictedVsObserved.png	0.9995
DDI_Qualification_P-gp/images/009_section_qualification-of-use-case-pgp-mediated-ddi/DDIRatio_1_perpetrator_Clarithromycin_ddi_ratio_plot_C_max_predictedVsObserved.png	0.9995
DDI_Qualification_P-gp/images/009_section_qualification-of-use-case-pgp-mediated-ddi/DDIRatio_1_perpetrator_Itraconazole_ddi_ratio_plot_C_max_residualsVsObserved.png	0.9995
DDI_Qualification_P-gp/images/009_section_qualification-of-use-case-pgp-mediated-ddi/DDIRatio_1_mechanism_Mechanism_based_Inactivation_ddi_ratio_plot_AUC_tEnd_predictedVsObserved.png	0.9998
DDI_Qualification_P-gp/images/009_section_qualification-of-use-case-pgp-mediated-ddi/DDIRatio_1_mechanism_Mechanism_based_Inactivation_ddi_ratio_plot_AUC_tEnd_residualsVsObserved.png	0.9998
DDI_Qualification_P-gp/images/009_section_qualification-of-use-case-pgp-mediated-ddi/DDIRatio_1_mechanism_Induction_ddi_ratio_plot_C_max_predictedVsObserved.png	0.9998
DDI_Qualification_P-gp/images/009_section_qualification-of-use-case-pgp-mediated-ddi/DDIRatio_1_perpetrator_Rifampicin_ddi_ratio_plot_C_max_predictedVsObserved.png	0.9998
DDI_Qualification_P-gp/images/009_section_qualification-of-use-case-pgp-mediated-ddi/DDIRatio_1_mechanism_Induction_ddi_ratio_plot_C_max_residualsVsObserved.png	0.9998
DDI_Qualification_P-gp/images/009_section_qualification-of-use-case-pgp-mediated-ddi/DDIRatio_1_perpetrator_Rifampicin_ddi_ratio_plot_C_max_residualsVsObserved.png	0.9998
DDI_Qualification_P-gp/images/010_section_concentration-time-profiles/014_section_verapamil-digoxin-ddi-timeprofile/comparison_time_profile_Pedersen_1982_23.png	0.9999
DDI_Qualification_P-gp/images/010_section_concentration-time-profiles/013_section_itraconazole-digoxin-ddi-timeprofile/comparison_time_profile_Jalava_1997_12.png	0.9999
DDI_Qualification_P-gp/images/009_section_qualification-of-use-case-pgp-mediated-ddi/DDIRatio_1_mechanism_Mechanism_based_Inactivation_ddi_ratio_plot_C_max_predictedVsObserved.png	0.9999
DDI_Qualification_P-gp/images/010_section_concentration-time-profiles/014_section_verapamil-digoxin-ddi-timeprofile/comparison_time_profile_Doering_1983_21.png	0.9999
DDI_Qualification_P-gp/images/009_section_qualification-of-use-case-pgp-mediated-ddi/DDIRatio_1_mechanism_Mechanism_based_Inactivation_ddi_ratio_plot_C_max_residualsVsObserved.png	0.9999
DDI_Qualification_P-gp/images/010_section_concentration-time-profiles/015_section_rifampicin-digoxin-ddi-timeprofile/comparison_time_profile_Gurley_2008_30.png	0.9999
DDI_Qualification_P-gp/images/010_section_concentration-time-profiles/012_section_erythromycin-digoxin-ddi-timeprofile/comparison_time_profile_Tsutsumi_2002___Plasma_11.png	1.0000
DDI_Qualification_P-gp/images/010_section_concentration-time-profiles/014_section_verapamil-digoxin-ddi-timeprofile/comparison_time_profile_Wiebe_2020_17.png	1.0000
DDI_Qualification_P-gp/images/009_section_qualification-of-use-case-pgp-mediated-ddi/DDIRatio_1_perpetrator_Verapamil_ddi_ratio_plot_AUC_tEnd_residualsVsObserved.png	1.0000
DDI_Qualification_P-gp/images/010_section_concentration-time-profiles/014_section_verapamil-digoxin-ddi-timeprofile/comparison_time_profile_Klein_1982_18.png	1.0000
DDI_Qualification_P-gp/images/010_section_concentration-time-profiles/014_section_verapamil-digoxin-ddi-timeprofile/comparison_time_profile_Schwartz_1982_19.png	1.0000

PDF Text Comparison

DDI_Qualification_P-gp/report.pdf

Text Differences (click to expand)

--- a/DDI_Qualification_P-gp/report.pdf
+++ b/DDI_Qualification_P-gp/report.pdf
@@ -1,7 +1,7 @@
 P-gp DDI Qualification

-Version 1.2-OSP12.3

+Version 1.2-OSP13.0

 Qualification Plan Release https://github.com/Open-Systems-Pharmacology/Qualification-DDI-P-gp/releases/tag/v1.2

-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

@@ -395,7 +395,7 @@
 Figure 2-4: Pgp DDI. Predicted/Observed vs. Observed C_max Ratio. (δ = 1 in Guest et al. formula)

 Table 2-1: GMFE for Pgp DDI Ratio

 PK parameter GMFE

-AUC_tEnd 1.24

+AUC_tEnd 1.23

 C_max 1.25

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

 AUC_tEnd Number Ratio [%]

@@ -415,12 +415,12 @@
 Ratio Ratio Ratio Ratio Ratio Ratio

 Rifampicin,

 600 mg, PO, Digoxin,

-191 0.70 0.70 1.01 1.13 0.48 2.34 Greiner 1999

+191 0.70 0.70 1.00 1.13 0.48 2.35 Greiner 1999

 MD OD (16 PO

 days)

 Rifampicin,

 600 mg, PO, Digoxin,

-193 0.73 0.85 0.86 0.91 0.83 1.09 Greiner 1999

+193 0.73 0.85 0.86 0.91 0.83 1.10 Greiner 1999

 MD OD (16 IV

 days)

 Rifampicin,

@@ -430,7 +430,7 @@
 days)

 Clarithromycin,

 500 mg, PO, Digoxin,

-229 1.26 1.47 0.86 1.42 1.75 0.81 Gurley 2008b

+229 1.28 1.47 0.87 1.41 1.75 0.81 Gurley 2008b

 MD BID (7 PO

 days)

 Itraconazole,

@@ -440,12 +440,12 @@
 days)

 Rifampicin,

 600 mg, PO, Digoxin,

-314 0.49 0.94 0.51 0.52 - - Kirby 2012

+314 0.48 0.94 0.51 0.52 - - Kirby 2012

 MD OD (14 PO

 days)

 Rifampicin,

 600 mg, PO, Digoxin,

-316 0.82 1.15 0.72 1.13 - - Kirby 2012

+316 0.82 1.15 0.71 1.13 - - Kirby 2012

 MD OD (14 PO

 days)

 Rifampicin,

@@ -455,7 +455,7 @@
 days)

 Rifampicin,

 600 mg, PO, Digoxin,

-396 1.11 1.46 0.76 1.21 1.49 0.81 Reitman 2011

+396 1.10 1.46 0.75 1.20 1.49 0.81 Reitman 2011

 MD OD (28 PO

 days)

 Rifampicin,

@@ -479,7 +479,7 @@
 days)

 Clarithromycin,

 200 mg, PO, Digoxin,

-3029 1.05 0.98 1.08 1.04 0.99 1.05 Tsutsumi 2002

+3029 1.06 0.98 1.08 1.04 0.99 1.05 Tsutsumi 2002

 MD BID (5 IV

 days)

 Verapamil, 80

@@ -514,12 +514,12 @@
 MD

 Clarithromycin,

 Digoxin,

-16307 400 mg, PO, 0.54 0.57 0.93 0.51 0.66 0.78 Kurata 2002

+16307 400 mg, PO, 0.54 0.57 0.94 0.51 0.66 0.78 Kurata 2002

 IV

 MD

 Clarithromycin,

 Digoxin,

-16309 400 mg, PO, 0.65 0.64 1.01 0.67 0.91 0.74 Kurata 2002

+16309 400 mg, PO, 0.65 0.64 1.01 0.67 0.91 0.73 Kurata 2002

 PO

 MD

 Clarithromycin,

@@ -529,7 +529,7 @@
 MD

 Clarithromycin,

 Digoxin,

-16313 400 mg, PO, 0.65 0.78 0.83 0.67 0.92 0.73 Kurata 2002

+16313 400 mg, PO, 0.65 0.78 0.82 0.67 0.92 0.73 Kurata 2002

 PO

 MD

 Clarithromycin,

@@ -543,17 +543,17 @@
 Ratio Ratio Ratio Ratio Ratio Ratio

 Rifampicin,

 Digoxin,

-16319 600 mg, PO, 0.68 0.73 0.93 0.88 0.81 1.09 Drescher 2003

+16319 600 mg, PO, 0.67 0.73 0.92 0.88 0.81 1.09 Drescher 2003

 IV

 MD

 Rifampicin,

 Digoxin,

-16322 300 mg, PO, 0.61 0.84 0.73 0.72 0.77 0.94 Gurley 2006

+16322 300 mg, PO, 0.61 0.84 0.72 0.72 0.77 0.94 Gurley 2006

 PO

 MD

 Clarithromycin,

 Digoxin,

-16324 500 mg, PO, 1.27 1.35 0.94 1.42 1.48 0.95 Gurley 2006

+16324 500 mg, PO, 1.29 1.35 0.95 1.41 1.48 0.95 Gurley 2006

 PO

 MD

 Rifampicin,

@@ -563,27 +563,27 @@
 MD

 Clarithromycin,

 Digoxin,

-16328 500 mg, PO, 1.27 1.57 0.81 1.42 1.95 0.73 Gurley 2007

+16328 500 mg, PO, 1.29 1.57 0.82 1.41 1.95 0.72 Gurley 2007

 PO

 MD

 Itraconazole,

 Digoxin,

-16329 200 mg, PO, 1.35 - - 1.39 1.63 0.85 Partanen 1996

+16329 200 mg, PO, 1.43 - - 1.43 1.63 0.88 Partanen 1996

 PO

 MD

 Itraconazole,

 Digoxin,

-16330 200 mg, PO, 1.37 - - 1.40 1.97 0.71 Partanen 1996

+16330 200 mg, PO, 1.47 - - 1.46 1.97 0.74 Partanen 1996

 PO

 MD

 Clarithromycin,

 250 mg, PO, Digoxin, Rengelshausen

-16409 1.06 1.19 0.89 1.00 - -

+16409 1.06 1.19 0.90 1.00 - -

 MD BID (3 IV 2003

 days)

 Clarithromycin,

 250 mg, PO, Digoxin, Rengelshausen

-16411 1.24 1.64 0.76 1.42 1.83 0.78

+16411 1.26 1.64 0.77 1.42 1.83 0.78

 MD BID (3 PO 2003

 days)

 Verapamil, 80 Digoxin,

@@ -604,7 +604,7 @@
 al. formula)

 Table 2-5: GMFE for Pgp DDI Ratio

 PK parameter GMFE

-AUC_tEnd 1.33

+AUC_tEnd 1.34

 C_max 1.27

 Table 2-6: Summary table for Pgp DDI - AUC_tEnd Ratio. (δ = 1 in Guest et al. formula)

 AUC_tEnd Number Ratio [%]

@@ -686,8 +686,8 @@
 Guest et al. formula)

 Table 2-14: GMFE for Pgp DDI Ratio

 PK parameter GMFE

-AUC_tEnd 1.12

-C_max 1.27

+AUC_tEnd 1.11

+C_max 1.28

 Table 2-15: Summary table for Pgp DDI - AUC_tEnd Ratio. (δ = 1 in Guest et al. formula)

 AUC_tEnd Number Ratio [%]

 Points total 12 -

@@ -741,7 +741,7 @@
 Table 2-20: GMFE for Pgp DDI Ratio

 PK parameter GMFE

 AUC_tEnd 1.33

-C_max 1.20

+C_max 1.18

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

 AUC_tEnd Number Ratio [%]

 Points total 1 -

@@ -767,7 +767,7 @@
 et al. formula)

 Table 2-23: GMFE for Pgp DDI Ratio

 PK parameter GMFE

-AUC_tEnd 1.33

+AUC_tEnd 1.34

 C_max 1.27

 Table 2-24: Summary table for Pgp DDI - AUC_tEnd Ratio. (δ = 1 in Guest et al. formula)

 AUC_tEnd Number Ratio [%]

@@ -820,7 +820,7 @@
 formula)

 Table 2-29: GMFE for Pgp DDI Ratio

 PK parameter GMFE

-AUC_tEnd 1.24

+AUC_tEnd 1.23

 C_max 1.25

 Table 2-30: Summary table for Pgp DDI - AUC_tEnd Ratio. (δ = 1 in Guest et al. formula)

 AUC_tEnd Number Ratio [%]

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