Most of the suitability criteria options have an associated section that controls what action is taken if a suitability criterion fails. Some have default options, other options may be required during an investigation or for gathering information for R&D from routine reports.
For information only
Yes / No
If selected, this criterion will be marked "For Information Only" in the report.
This option enables users to set criteria that they wish to track or investigate,
but are not to be regarded as part of the regulatory report.
Continue assay on failure
Yes / No
If selected, the report analysis will continue to the next steps even if a criterion fails.
Print RP on failure
Yes / No
If selected, and the "continue" option is also selected, the report will print a value for the RP despite criteria failure.
A = intercept, B = slope
System Suitability
Type
Test group
Test
Criteria
Default values
Control wells
Descriptive statistics
Mean of the group
Upper and lower limit
Geometric mean of the group
Sum of the group
Reference
Test group
Test
Criteria
Default values
Goodness of fit
Goodness of fit (Linearity on logit/probit scale)
p-value for z test for quadratic model.
Critical p value.
Default where no test specified (p=0.05)
Parameter values:
Allowed range for ref parameters
Intercept (A)
Upper and lower limit.
Slope (B)
Equivalence tests for ref parameters
CI for intercept (A)
Confidence level.
Upper and lower limit.
CI for slope (B).
Significance of slope (dose response)
p-value for B being significantly different from zero
Critical p-value.
Whether the slope should be positive or negative.
Default where no test specified (p=0.05)
Allowed range for combination of ref parameters
Midpoint (-A/B)
Upper and lower limit.
Equivalence tests for combinations of ref parameters
CI for midpoint (-A/B).
Confidence level.
Upper and lower limit.
Variability of data:
Variability
Log-likelihood (Chi squared test)
Lower limit for log-likelihood.
Quality Control (QC)
Test group
Test
Criteria
Default values
Goodness of fit:
Goodness of fit (Linearity)
p-value for z test for quadratic model.
Critical p value.
Default where no test specified (p=0.05)
Parameter values:
Significance of slope (dose response)
p-value for slope (B) significantly different from zero
Critical p-value.
Whether the slope should be positive or negative.
Parallelism test:
Allowed ranges for combinations of parameters
Slope difference
Upper and lower limits
Slope ratio
Normalised slope difference
Equivalence tests for combinations of parameters
CI for range parameters above
(Delta Method or Fieller's Theorem)
Confidence level for CI.
CI Upper and lower limits
Slope ratio
Normalised slope difference
Parallelism
Chi squared test
Critical p-value
Default (p=0.05)
Relative potency
Allowed range for relative potency
Relative potency
Upper and lower limit
Equivalence test for relative potency
CI for the relative potency.
Confidence level for the CI.
Upper and lower limits
Precision
Ratio of the upper and lower ends of the CI for the RP, after back-transformation.
