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14 changes: 7 additions & 7 deletions DDI_Qualification_CYP1A2/report.md
Original file line number Diff line number Diff line change
@@ -1,9 +1,9 @@
# 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:
Expand Down Expand Up @@ -338,11 +338,11 @@ In the plots,
|DataID |Perpetrator |Victim |Predicted AUC Ratio |Observed AUC Ratio |Pred/Obs AUC Ratio |Predicted CMAX Ratio |Observed CMAX Ratio |Pred/Obs CMAX Ratio |Reference |
|:------|:------------------------------|:--------------|:-------------------|:------------------|:------------------|:--------------------|:-------------------|:-------------------|:----------------|
|6110 |Ethinylestradiol, 0.03 mg, PO, |Caffeine, PO |5.84 |2.13 |2.74 |1.10 |1.15 |0.96 |Balogh 1995 |
|13017 |Fluvoxamine, 100 mg, PO, |Tizanidine, PO |39.12 |33.00 |1.19 |16.00 |12.10 |1.32 |Granfors 2004 |
|13017 |Fluvoxamine, 100 mg, PO, |Tizanidine, PO |38.77 |33.00 |1.17 |15.95 |12.10 |1.32 |Granfors 2004 |
|13018 |Mexiletine, 50 mg, PO, |Tizanidine, PO |2.48 |3.42 |0.73 |2.42 |3.22 |0.75 |Momo 2010 |
|14002 |Ethinylestradiol, 20 mg, PO, |Tizanidine, PO |4.41 |3.92 |1.13 |3.75 |3.02 |1.24 |Granfors 2005 |
|14004 |Fluvoxamine, 100 mg, PO, |Caffeine, PO |9.97 |7.16 |1.39 |1.08 |1.09 |0.99 |Jeppesen 1996 |
|14006 |Fluvoxamine, 100 mg, PO, |Caffeine, PO |13.64 |13.71 |0.99 |1.34 |1.40 |0.96 |Culm-Merdek 2005 |
|14004 |Fluvoxamine, 100 mg, PO, |Caffeine, PO |10.02 |7.16 |1.40 |1.08 |1.09 |0.99 |Jeppesen 1996 |
|14006 |Fluvoxamine, 100 mg, PO, |Caffeine, PO |13.65 |13.71 |1.00 |1.34 |1.40 |0.96 |Culm-Merdek 2005 |
|14008 |Mexiletine, 200 mg, PO, |Caffeine, PO |1.66 |2.83 |0.59 |1.00 |1.89 |0.53 |Joeres 1987 |
|14010 |Fluvoxamine, 50 mg, PO, |Mexiletine, PO |1.31 |1.55 |0.84 |1.08 |1.16 |0.93 |Kusumoto 2001 |

Expand Down Expand Up @@ -701,7 +701,7 @@ In the plots,

|PK parameter |GMFE |
|:------------|:----|
|AUC |1.19 |
|AUC |1.18 |
|CMAX |1.07 |

<br>
Expand Down Expand Up @@ -777,7 +777,7 @@ In the plots,

|PK parameter |GMFE |
|:------------|:----|
|AUC |1.23 |
|AUC |1.22 |
|CMAX |1.30 |

<br>
Expand Down
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