Update Qualification Report for Pediatric_Qualification_Package_CYP2C8_Ontogeny#241
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Image and PDF Comparison ReportImage SimilaritySimilarity Range: 0.9462 - 0.9537 PDF Text ComparisonPediatric_Qualification_Package_CYP2C8_Ontogeny/report.pdfText Differences (click to expand)--- a/Pediatric_Qualification_Package_CYP2C8_Ontogeny/report.pdf
+++ b/Pediatric_Qualification_Package_CYP2C8_Ontogeny/report.pdf
@@ -1,9 +1,9 @@
Pediatric Qualification Package: CYP2C8
Ontogeny
-Version 2.0-OSP12.3
+Version 2.0-OSP13.0
Qualification Plan https://github.com/Open-Systems-
Release Pharmacology/Pediatric_Qualification_Package_CYP2C8_Ontogeny/releases/tag/v2.0
-OSP Version 12.3
+OSP Version 13.0
Qualification Framework
3.7
Version
@@ -104,15 +104,15 @@
lines represent the 1.5-fold and 2-fold error, respectively.
Number Ratio [%]
Points total 56 -
-Points within 1.5 fold 36 64.29
-Points within 2 fold 50 89.29
+Points within 1.5 fold 35 62.50
+Points within 2 fold 49 87.50
Table 2-2: GMFE for Overall predictivity of the montelukast PBPK model as an in vivo marker of
CYP2C8 mediated clearance. Open circles represent mean ratios of PBPK predicted AUC over
6/19
observed AUC of in children 1 month to 11.9 years old. Blue dashed lines and red dotted lines
represent the 1.5-fold and 2-fold error, respectively.
Parameter GMFE
-AUC 1.40
+AUC 1.42
Table 2-3: Overall predictivity of the montelukast PBPK model as an in vivo marker of CYP2C8
mediated clearance. Open circles represent mean ratios of PBPK predicted AUC over observed
AUC of in children 1 month to 11.9 years old. Blue dashed lines and red dotted lines represent
@@ -122,178 +122,178 @@
Study ID
[year(s)] [kg] [µg*h/l] [µg*h/l] Ratio
Kearns
-0.08 4.04 20846.61 30336.98 0.69
-2008
-Kearns
-0.08 4.04 20846.61 29350.14 0.71
-2008
-Kearns
-0.08 4.04 20846.61 19481.80 1.07
-2008
-Kearns
-0.08 4.04 20846.61 15271.04 1.37
-2008
-Kearns
-0.08 4.04 20846.61 14152.63 1.47
-2008
-Kearns
-0.17 4.58 10046.03 19490.31 0.52
-2008
-Kearns
-0.17 4.58 10046.03 17384.80 0.58
-2008
-Kearns
-0.17 4.58 10046.03 16069.03 0.63
-2008
-Kearns
-0.17 4.58 10046.03 14555.88 0.69
-2008
-Kearns
-0.17 4.58 10046.03 12845.36 0.78
-2008
-Kearns
-0.17 4.58 10046.03 10016.44 1.00
-2008
-Kearns
-0.25 5.13 8802.04 10024.69 0.88
-2008
-Kearns
-0.25 5.13 8802.04 8774.44 1.00
-2008
-Kearns
-0.25 5.13 8802.04 6998.66 1.26
-2008
-Kearns
-0.25 5.13 8802.04 5419.72 1.62
-2008
-Kearns
-0.25 5.13 8802.04 5024.99 1.75
+0.08 4.04 21816.43 30336.98 0.72
+2008
+Kearns
+0.08 4.04 21816.43 29350.14 0.74
+2008
+Kearns
+0.08 4.04 21816.43 19481.80 1.12
+2008
+Kearns
+0.08 4.04 21816.43 15271.04 1.43
+2008
+Kearns
+0.08 4.04 21816.43 14152.63 1.54
+2008
+Kearns
+0.17 4.58 10523.49 19490.31 0.54
+2008
+Kearns
+0.17 4.58 10523.49 17384.80 0.61
+2008
+Kearns
+0.17 4.58 10523.49 16069.03 0.65
+2008
+Kearns
+0.17 4.58 10523.49 14555.88 0.72
+2008
+Kearns
+0.17 4.58 10523.49 12845.36 0.82
+2008
+Kearns
+0.17 4.58 10523.49 10016.44 1.05
+2008
+Kearns
+0.25 5.13 9226.31 10024.69 0.92
+2008
+Kearns
+0.25 5.13 9226.31 8774.44 1.05
+2008
+Kearns
+0.25 5.13 9226.31 6998.66 1.32
+2008
+Kearns
+0.25 5.13 9226.31 5419.72 1.70
+2008
+Kearns
+0.25 5.13 9226.31 5024.99 1.84
2008
8/19
Age Body Weight Predicted AUC Observed AUC Pred/Obs AUC
Study ID
[year(s)] [kg] [µg*h/l] [µg*h/l] Ratio
Kearns
-0.25 5.13 8802.04 3709.21 2.37
-2008
-Kearns
-0.33 5.67 8681.58 9835.07 0.88
-2008
-Kearns
-0.33 5.67 8681.58 6941.12 1.25
-2008
-Kearns
-0.42 6.21 8698.70 10369.89 0.84
-2008
-Kearns
-0.42 6.21 8698.70 9843.32 0.88
-2008
-Kearns
-0.42 6.21 8698.70 6488.08 1.34
-2008
-Kearns
-0.42 6.21 8698.70 3791.25 2.29
-2008
-Kearns
-0.42 6.21 8698.70 3462.05 2.51
-2008
-Kearns
-0.50 6.75 9614.11 6167.91 1.56
-2008
-Kearns
-0.58 7.29 9805.12 11833.50 0.83
-2008
-Kearns
-0.67 7.83 9987.51 10986.76 0.91
-2008
-Kearns
-0.67 7.83 9987.51 10394.92 0.96
-2008
-Kearns
-0.67 7.83 9987.51 8289.15 1.20
-2008
-Kearns
-0.75 8.38 10137.93 10534.24 0.96
-2008
-Kearns
-0.75 8.38 10137.93 4612.97 2.20
-2008
-Kearns
-0.83 8.92 10286.73 3897.29 2.64
+0.25 5.13 9226.31 3709.21 2.49
+2008
+Kearns
+0.33 5.67 9100.24 9835.07 0.93
+2008
+Kearns
+0.33 5.67 9100.24 6941.12 1.31
+2008
+Kearns
+0.42 6.21 9113.41 10369.89 0.88
+2008
+Kearns
+0.42 6.21 9113.41 9843.32 0.93
+2008
+Kearns
+0.42 6.21 9113.41 6488.08 1.40
+2008
+Kearns
+0.42 6.21 9113.41 3791.25 2.40
+2008
+Kearns
+0.42 6.21 9113.41 3462.05 2.63
+2008
+Kearns
+0.50 6.75 10063.80 6167.91 1.63
+2008
+Kearns
+0.58 7.29 10255.33 11833.50 0.87
+2008
+Kearns
+0.67 7.83 10437.79 10986.76 0.95
+2008
+Kearns
+0.67 7.83 10437.79 10394.92 1.00
+2008
+Kearns
+0.67 7.83 10437.79 8289.15 1.26
+2008
+Kearns
+0.75 8.38 10587.72 10534.24 1.01
+2008
+Kearns
+0.75 8.38 10587.72 4612.97 2.30
+2008
+Kearns
+0.83 8.92 10736.76 3897.29 2.75
2008
9/19
Age Body Weight Predicted AUC Observed AUC Pred/Obs AUC
Study ID
[year(s)] [kg] [µg*h/l] [µg*h/l] Ratio
Kearns
-0.92 9.46 10426.56 15879.40 0.66
-2008
-Kearns
-0.92 9.46 10426.56 13116.26 0.79
-2008
-Kearns
-0.92 9.46 10426.56 5155.53 2.02
-2008
-Kearns
-1.00 10.00 10563.87 18848.16 0.56
-2008
-Kearns
-1.00 10.00 10563.87 7334.83 1.44
-2008
-Kearns
-1.00 10.00 10563.87 5690.10 1.86
-2008
-Kearns
-1.17 10.38 10779.51 6167.14 1.75
-2008
-Kearns
-1.42 10.94 11130.88 11060.03 1.01
-2008
-Kearns
-1.58 11.31 11324.86 15221.25 0.74
-2008
-Kearns
-1.58 11.31 11324.86 8642.35 1.31
-2008
-Kearns
-1.58 11.31 11324.86 7392.36 1.53
-2008
-Kearns
-1.58 11.31 11324.86 5945.00 1.90
-2008
-Kearns
-1.67 11.50 11424.61 14374.25 0.79
-2008
-Kearns
-1.67 11.50 11424.61 11940.31 0.96
-2008
-Kearns
-1.67 11.50 11424.61 11414.00 1.00
-2008
-Kearns
-1.67 11.50 11424.61 10558.23 1.08
+0.92 9.46 10877.29 15879.40 0.68
+2008
+Kearns
+0.92 9.46 10877.29 13116.26 0.83
+2008
+Kearns
+0.92 9.46 10877.29 5155.53 2.11
+2008
+Kearns
+1.00 10.00 11015.81 18848.16 0.58
+2008
+Kearns
+1.00 10.00 11015.81 7334.83 1.50
+2008
+Kearns
+1.00 10.00 11015.81 5690.10 1.94
+2008
+Kearns
+1.17 10.38 11236.49 6167.14 1.82
+2008
+Kearns
+1.42 10.94 11596.87 11060.03 1.05
+2008
+Kearns
+1.58 11.31 11795.48 15221.25 0.77
+2008
+Kearns
+1.58 11.31 11795.48 8642.35 1.36
+2008
+Kearns
+1.58 11.31 11795.48 7392.36 1.60
+2008
+Kearns
+1.58 11.31 11795.48 5945.00 1.98
+2008
+Kearns
+1.67 11.50 11897.65 14374.25 0.83
+2008
+Kearns
+1.67 11.50 11897.65 11940.31 1.00
+2008
+Kearns
+1.67 11.50 11897.65 11414.00 1.04
+2008
+Kearns
+1.67 11.50 11897.65 10558.23 1.13
2008
10/19
Age Body Weight Predicted AUC Observed AUC Pred/Obs AUC
Study ID
[year(s)] [kg] [µg*h/l] [µg*h/l] Ratio
Kearns
-1.75 11.69 11520.13 12013.84 0.96
-2008
-Kearns
-1.75 11.69 11520.13 9250.71 1.25
+1.75 11.69 11995.57 12013.84 1.00
+2008
+Kearns
+1.75 11.69 11995.57 9250.71 1.30
2008
Friesen
-11.90 40.55 4428.28 4387.20 1.01
+11.90 40.55 4665.76 4387.20 1.06
2004
-Knorr 1999 7.00 26.00 3480.98 2929.00 1.19
-Knorr 2001 4.00 17.00 3382.76 2721.00 1.24
-Knorr 2006 0.33 6.80 5964.28 3644.30 1.64
+Knorr 1999 7.00 26.00 3486.66 2929.00 1.19
+Knorr 2001 4.00 17.00 3484.83 2721.00 1.28
+Knorr 2006 0.33 6.80 6212.97 3644.30 1.70
Miyoga
-1.50 9.00 4454.64 3629.20 1.23
+1.50 9.00 4624.10 3629.20 1.27
2004
Miyoga
-0.75 9.00 4819.09 2470.90 1.95
+0.75 9.00 5000.36 2470.90 2.02
2004
2.1 Montelukast PK Ratio tables and Figures
Montelukast model
@@ -341,14 +341,14 @@
error, respectively.
Number Ratio [%]
Points total 56 -
-Points within 1.5 fold 36 64.29
-Points within 2 fold 50 89.29
+Points within 1.5 fold 35 62.50
+Points within 2 fold 49 87.50
Table 2-5: GMFE for Overall predictivity of the montelukast PBPK model. Open circles represent
mean ratios of PBPK predicted AUC over observed AUC of montelukast in children 1 month to
11.9 years old. Blue dashed lines and red dotted lines represent the 1.5-fold and 2-fold error,
respectively.
Parameter GMFE
-AUC 1.40
+AUC 1.42
Table 2-6: Overall predictivity of the montelukast PBPK model. Open circles represent mean
ratios of PBPK predicted AUC over observed AUC of montelukast in children 1 month to 11.9
years old. Blue dashed lines and red dotted lines represent the 1.5-fold and 2-fold error,
@@ -358,178 +358,178 @@
Study ID
[year(s)] [kg] [µg*h/l] [µg*h/l] Ratio
Kearns
-0.08 4.04 20846.61 30336.98 0.69
-2008
-Kearns
-0.08 4.04 20846.61 29350.14 0.71
-2008
-Kearns
-0.08 4.04 20846.61 19481.80 1.07
-2008
-Kearns
-0.08 4.04 20846.61 15271.04 1.37
-2008
-Kearns
-0.08 4.04 20846.61 14152.63 1.47
-2008
-Kearns
-0.17 4.58 10046.03 19490.31 0.52
-2008
-Kearns
-0.17 4.58 10046.03 17384.80 0.58
-2008
-Kearns
-0.17 4.58 10046.03 16069.03 0.63
-2008
-Kearns
-0.17 4.58 10046.03 14555.88 0.69
-2008
-Kearns
-0.17 4.58 10046.03 12845.36 0.78
-2008
-Kearns
-0.17 4.58 10046.03 10016.44 1.00
-2008
-Kearns
-0.25 5.13 8802.04 10024.69 0.88
-2008
-Kearns
-0.25 5.13 8802.04 8774.44 1.00
-2008
-Kearns
-0.25 5.13 8802.04 6998.66 1.26
-2008
-Kearns
-0.25 5.13 8802.04 5419.72 1.62
-2008
-Kearns
-0.25 5.13 8802.04 5024.99 1.75
+0.08 4.04 21816.43 30336.98 0.72
+2008
+Kearns
+0.08 4.04 21816.43 29350.14 0.74
+2008
+Kearns
+0.08 4.04 21816.43 19481.80 1.12
+2008
+Kearns
+0.08 4.04 21816.43 15271.04 1.43
+2008
+Kearns
+0.08 4.04 21816.43 14152.63 1.54
+2008
+Kearns
+0.17 4.58 10523.49 19490.31 0.54
+2008
+Kearns
+0.17 4.58 10523.49 17384.80 0.61
+2008
+Kearns
+0.17 4.58 10523.49 16069.03 0.65
+2008
+Kearns
+0.17 4.58 10523.49 14555.88 0.72
+2008
+Kearns
+0.17 4.58 10523.49 12845.36 0.82
+2008
+Kearns
+0.17 4.58 10523.49 10016.44 1.05
+2008
+Kearns
+0.25 5.13 9226.31 10024.69 0.92
+2008
+Kearns
+0.25 5.13 9226.31 8774.44 1.05
+2008
+Kearns
+0.25 5.13 9226.31 6998.66 1.32
+2008
+Kearns
+0.25 5.13 9226.31 5419.72 1.70
+2008
+Kearns
+0.25 5.13 9226.31 5024.99 1.84
2008
14/19
Age Body Weight Predicted AUC Observed AUC Pred/Obs AUC
Study ID
[year(s)] [kg] [µg*h/l] [µg*h/l] Ratio
Kearns
-0.25 5.13 8802.04 3709.21 2.37
-2008
-Kearns
-0.33 5.67 8681.58 9835.07 0.88
-2008
-Kearns
-0.33 5.67 8681.58 6941.12 1.25
-2008
-Kearns
-0.42 6.21 8698.70 10369.89 0.84
-2008
-Kearns
-0.42 6.21 8698.70 9843.32 0.88
-2008
-Kearns
-0.42 6.21 8698.70 6488.08 1.34
-2008
-Kearns
-0.42 6.21 8698.70 3791.25 2.29
-2008
... (truncated 205 lines)
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