System Suitability Criteria

Controls

, or ‘linearity’

If there is more than one replicate at each dose: lack of fit error can be compared with pure error via an F test.
The level (critical p value) can be chosen by the user.
Default is 0.05.
A quadratic model can be fitted to the data and the significance of the quadratic term tested via a t test.
The level (critical p value) can be chosen by the user.
Default is 0.05.
The R²for the regression can be calculated.
The minimum value must be chosen by the user (no default setting).

Parameter values
Ranges for parameter values A_Ref, B_Refcan be set.
Equivalence limits for A_Ref, B_Refcan be set:
Ranges for the confidence intervals for A_Ref, B_Ref(no default setting).
The confidence level for the each interval can be chosen by the user (no default setting).

Statistical significance of the slope
, B_Refvia a one-sample t test comparing the slope with zero.
The level (critical P value) can be chosen by the user
Default is 0.05.
The sign of the slope must be stated (positive or negative).

Variability of data
An upper limit for the variance, σ²_Ref, can be set.
An upper limit for the root mean square error (RMSE) can be set.

, or ‘linearity’

If there is more than one replicate at each dose: lack of fit error can be compared with pure error via an F test.
The level (critical p value) can be chosen by the user.
Default is 0.05.
A quadratic model can be fitted to the data and the significance of the quadratic term tested via a t test.
The level (critical p value) can be chosen by the user.
Default is 0.05.
The R²for the regression can be calculated.
The minimum value must be chosen by the user (no default setting).

, B_QC via a one-sample t test comparing the slope with zero.

The level (critical p value) can be chosen by the user
Default is 0.05.
The sign of the slope must be stated (positive or negative).

Parallelism with reference standard
Ranges for combinations of QC and reference slope parameters can be chosen.
Difference between slopes:
Ratio of slopes:
Normalised slope difference:
Equivalence tests for combinations of QC and reference slope parameters.
Ranges for the confidence intervals (no default setting) for:
Difference between slopes:
Ratio of slopes:
Normalised slope difference:
The confidence level for the each interval can be chosen by the user (no default setting).
Significance tests for lack of parallelism can be used:
F test comparing the model with separate slopes with the parallel model.
The level (critical P value) can be chosen by the user.
Default is 0.05.
χ² test comparing the model with separate slopes with the parallel model.
The level (critical P value) can be chosen by the user (no default setting).

Relative potency of the QC sample
, and its confidence interval (For calculation of these parameters, see 3.1.5 below)

a) Allowed range for RP

b) Equivalence test for RP
Range for the confidence interval for RP (no default setting).
The confidence level can be chosen by the user (no default setting).

c) Precision: The ratio of upper confidence limit to lower confidence limit
The confidence level can be chosen by the user (no default setting).
The upper limit for the precision is chosen by the user