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【資料No.1】2.5_臨床に関する概括資料 (36 ページ)
出典
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| 出典情報 | 薬事・食品衛生審議会 薬事分科会（令和4年度第5回 11／22）、医薬品第二部会（令和4年度第13回 11／22）（合同開催）《厚生労働省》 |
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S-217622
2.5 臨床に関する概括評価
表 2.5.3.1-11
母集団薬物動態パラメータ推定値
Pharmacokinetic parameters
Units
Estimates
%RSE
Ka
(1/hr)
1.44
10.2
CL/F
(L/hr)
0.247
2.1
Vc/F
(L)
15.5
3.6
Q/F
(L/hr)
0.709
24.5
Vp/F
(L)
2.85
16.4
Effect of food on Ka
0.594
23.7
Effect of formulation on Ka
0.371
14.9
Effect of body weight on CL/F
0.524
12.8
Effect of health status on CL/F
0.776
2.8
Effect of body weight on Vc/F
1.06
6.3
Inter-individual variability
Ka
%
73.1
13.2
CL/F
%
19.1
12.0
Vc/F
%
14.2
14.7
0.0169 (R = 0.621)
15.3
Covariance between CL/F and Vc/F
Intra-individual variability
Proportional residual error
%
20.9
5.6
Shrinkage
sh_ηp (Ka)
%
50.1
-
sh_ηp (CL/F)
%
24.3
-
sh_ηp (Vc/F)
%
31.2
-
sh_ε
%
6.2
-
R = coefficient of correlation; sh_ηp = shrinkage in the standard deviation of inter-individual variability parameters η;
sh_ε = shrinkage in the standard deviation of intra-individual variability parameters ε;
%RSE = relative standard error in percent
Ka = 1.44 × (0.594 for food) × (0.371 for formulation)
CL/F = 0.247 × (body weight/63.0) 0.524 × (0.776 for health status)
Vc/F = 15.5 × (body weight/63.0) 1.06
Q/F = 0.709
Vp/F = 2.85
food: 1 = administration within 2 hours after meal, 0 = other; formulation: 1 = tablet, 0 = suspension;
health status: 1 = infected by SARS-CoV-2, 0 = healthy
出典：5.3.3.5-01_S-217622-CPK-016-B_Amendment1_Table S1_改訂
- 36 -
2.5 臨床に関する概括評価
表 2.5.3.1-11
母集団薬物動態パラメータ推定値
Pharmacokinetic parameters
Units
Estimates
%RSE
Ka
(1/hr)
1.44
10.2
CL/F
(L/hr)
0.247
2.1
Vc/F
(L)
15.5
3.6
Q/F
(L/hr)
0.709
24.5
Vp/F
(L)
2.85
16.4
Effect of food on Ka
0.594
23.7
Effect of formulation on Ka
0.371
14.9
Effect of body weight on CL/F
0.524
12.8
Effect of health status on CL/F
0.776
2.8
Effect of body weight on Vc/F
1.06
6.3
Inter-individual variability
Ka
%
73.1
13.2
CL/F
%
19.1
12.0
Vc/F
%
14.2
14.7
0.0169 (R = 0.621)
15.3
Covariance between CL/F and Vc/F
Intra-individual variability
Proportional residual error
%
20.9
5.6
Shrinkage
sh_ηp (Ka)
%
50.1
-
sh_ηp (CL/F)
%
24.3
-
sh_ηp (Vc/F)
%
31.2
-
sh_ε
%
6.2
-
R = coefficient of correlation; sh_ηp = shrinkage in the standard deviation of inter-individual variability parameters η;
sh_ε = shrinkage in the standard deviation of intra-individual variability parameters ε;
%RSE = relative standard error in percent
Ka = 1.44 × (0.594 for food) × (0.371 for formulation)
CL/F = 0.247 × (body weight/63.0) 0.524 × (0.776 for health status)
Vc/F = 15.5 × (body weight/63.0) 1.06
Q/F = 0.709
Vp/F = 2.85
food: 1 = administration within 2 hours after meal, 0 = other; formulation: 1 = tablet, 0 = suspension;
health status: 1 = infected by SARS-CoV-2, 0 = healthy
出典：5.3.3.5-01_S-217622-CPK-016-B_Amendment1_Table S1_改訂
- 36 -