Most of the suitability criteria options have an associated section that controls what action is taken if a suitability criterion fails.
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.
System Suitability
Test group
Test
Criteria
Default values
Control Wells
Descriptive statistics
Mean of the group
Upper and lower limit
Mean of individual "lines"
Geometric mean of the group
Geometric mean of individual "lines"
Reference
Test group
Test
Criteria
Default values
Goodness of fit
Goodness of fit
(Automatic selection)
p-value for F test if more than one replicate.
p-value for likelihood ratio test (chi-squared test) for 5PL model if not
Critical p value
Default p=0.01
Parameter values
Allowed ranges for parameters
A
Upper and lower limit
B
C
D
Equivalence tests for parameters
CI for A
Confidence level
Upper and lower limits
CI for B
CI for C
CI for D
Significance of dose response
p-value for B being significantly different from zero
Critical p-value.
Default p=0.01
Range
Limits for |D-A|
Upper and lower limits
CI for |D-A|
Confidence level
Upper and lower limits
Variability of data
Variability
Variance estimate
Upper limit
Root Mean Square Error (RMSE)
Upper limit
Quality Control
Test group
Test
Criteria
Default values
Goodness of fit
Goodness of fit
p-value for F test if more than one replicate.
p-value for likelihood ratio test (chi-squared test) for 5PL model if not
Critical p value
p=0.01
Parameter values
Significance of dose response
p-value for B being significantly different from zero
Critical p-value
Parallelism tests
Ranges for combinations of parameters
A difference
Upper and lower limits
D Difference
Normalised A difference
Normalised D difference
Range for B difference
Range for Slope ratio
Equivalence tests for combinations of parameters
CI for A Difference
(Delta Method or Fieller's)
Confidence level for CI.
CI Upper and lower limits
CI for D Difference
CI for Normalised A difference
CI for Normalised D difference
CI for B difference
CI for Slope ratio
Significance tests
F test
Critical p-value
Chi squared test
Critical p-value
Relative potency tests
Allowed range
Relative potency
Upper and lower limits
Equivalence test
Confidence interval for relative potency
Confidence level for CI.
CI Upper and lower limits
Precision
Ratio of the upper and lower ends of the CI for the RP, after back-transformation.
