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.
Sample Suitability
Test
Test statistic
User has to specify
Comments
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 B significantly different from zero
Critical p-value.
Whether the slope should be positive or negative.
Parallelism tests:
Allowed ranges for combinations of parameters
Slope difference
Upper and lower limit.
Slope ratio
Normalised slope difference
Equivalence tests for combinations of parameters
Slope difference
Confidence level. Delta method or Fieller's Theorem
