System Suitability Criteria
System suitability criteria available within QuBAS for the 4PL model are:
Controls
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Upper and lower limits can be set for the mean or geometric mean of:
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By groups if present e.g. high, low
Reference standard
Goodness of fit of the model
(Automatic selection)
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If there is more than one replicate at each dose: lack of fit error can be compared with pure error via an F test.
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The level (critical p value) can be chosen by the user.
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A 5PL model can be fitted to the data and compared with the 4PL fit via a likelihood ratio test (chi-squared test).
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The level (critical p value) can be chosen by the user.
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Parameter values
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-
-
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The confidence level for the each interval can be chosen by the user (no default setting).
Statistical significance of Dose response 
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via a one-sample t test comparing
with zero.
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The level (critical p value) can be chosen by the user
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Range
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Range (difference between asymptotes): limits for the value of |
can be set.
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Range (difference between asymptotes): equivalence limits for |
can be set:
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Range for the confidence intervals for |
(no default setting).
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The confidence level for the each interval can be chosen by the user (no default setting).
Variability of data
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An upper limit for the variance, σ2Ref, mean square error (MSE) can be set.
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An upper limit for σRef the root mean square error (RMSE) can be set.
Quality Control
Goodness of fit of the model
-
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.
-
-
A 5PL model can be fitted to the data and compared with the 4PL via a likelihood ratio test.
-
The level (critical p value) can be chosen by the user.
-
Statistical significance of
a) Via a one-sample t test comparing
with zero.
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The level (critical p value) can be chosen by the user
-
Parallelism with reference standard
a) Ranges for combinations of QC and reference parameters can be chosen.
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Difference between equivalent parameters:
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(

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(

-
(

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Normalised difference between asymptotes
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b) Equivalence tests for combinations of QC and reference parameters.
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Ranges for the confidence intervals (no default setting) for:
-
(

-
(

-
(

-
-
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The confidence level for the each interval can be chosen by the user (no default setting).
c) Significance tests for lack of parallelism can be used:
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The level (critical p value) can be chosen by the user.
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-
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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 3.2.5 below.)