NCA Specification
1
NCA Specifications
2
Introduction
2.1
Scope
2.2
Out of scope
3
Input Data
3.1
SDTM Alignment
3.2
Output Data
4
Equations
4.1
Defined Parameters
4.2
Parameter Table
4.3
Notes
4.4
\(C_{min}\)
4.5
\(C_{trough}\)
4.6
\(C_{last,pred}\)
4.7
\(AUC_{0,t}\)
,
\(AUC_{last}\)
,
\(AUC_{\tau}\)
4.8
\(AUC_{t_{last}-\infty,pred}\)
,
\(AUC_{t_{last}-\infty,obs}\)
4.9
\(AUC_{t_{last}-\infty,all}\)
4.10
\(AUC_{0-\infty,pred}\)
,
\(AUC_{0-\infty,obs}\)
4.11
\(AUC_{0,all}\)
4.12
\(AUC_{\%extrap,obs}\)
,
\(AUC_{\%extrap,pred}\)
4.13
\(F\)
4.14
\(AUMC_{0,t}\)
,
\(AUMC_{last}\)
,
\(AUMC_{\tau}\)
4.15
\(AUMC_{t_{last}-\infty,obs}\)
,
\(AUMC_{t_{last}-\infty,pred}\)
4.16
\(AUMC_{t_{last}-\infty,all}\)
4.17
\(AUMC_{0-\infty,obs}\)
,
\(AUMC_{0-\infty,pred}\)
4.18
\(AUMC_{0,all}\)
4.19
\(AUMC_{\%extrap,obs}\)
,
\(AUMC_{\%extrap,pred}\)
4.20
\(\lambda_z\)
4.21
\(N_{\lambda_z}\)
4.22
\(r^2\)
4.23
\(r^2_{adj}\)
4.24
\(MRT_{ev,last}\)
,
\(MRT_{ev,\infty,obs}\)
,
\(MRT_{ev,\infty,pred}\)
,
\(MRT_{iv,last}\)
,
\(MRT_{iv,\infty,obs}\)
,
\(MRT_{iv,\infty,pred}\)
4.25
\(MAT_{last}\)
,
\(MAT_{\infty,obs}\)
,
\(MAT_{\infty,pred}\)
4.26
\(R_{A,AUC}\)
4.27
\(R_{A,C_{max}}\)
4.28
\(R_{A,C_{min}}\)
4.29
\(R_{A,C_{trough}}\)
4.30
\(CL_{ev,obs}\)
,
\(CL_{ev,pred}\)
,
\(CL_{ev,\tau}\)
,
\(CL_{iv,obs}\)
,
\(CL_{iv,pred}\)
,
\(CL_{iv,\tau}\)
4.31
\(V_{ss,obs}\)
,
\(V_{ss,pred}\)
4.32
\(C_0\)
4.33
\(AUC_{\%backextrap,obs}\)
,
\(AUC_{\%backextrap,pred}\)
4.34
References
5
Test Cases
5.1
Introduction
5.2
Examples
6
Deviations
6.1
Introduction
6.2
Limit of Quantification Modifications
6.3
Time Deviation Correction Rules
6.4
Concentration Deviation Correction Rules
6.5
Interpolation
6.5.1
Zero Interpolation
6.5.2
Linear Interpolation
6.5.3
Log-Linear Interpolation
6.6
Extrapolation
7
Deviation Examples
8
SDT
8.1
SDT-1
8.2
SDT-2
8.3
SDT-3
9
MDT
9.1
MDT-1
9.2
MDT-2
9.3
MDT-3
10
SDC
10.1
SDC-1
10.2
SDC-2
10.3
SDC-3
10.4
SDC-4a
10.5
SDC-4b
10.6
SDC-4c
10.7
SDC-4d
11
MDC
11.1
MDC-1
11.2
MDC-2
11.3
MDC-3
11.4
MDC-4a
11.5
MDC-4b
11.6
MDC-4c
11.7
MDC-4d
12
Session Information
NCA Specification
NCA Specifications
Chapter 7
Deviation Examples