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 group
Test
Criteria
Default values
Type
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
Default p=0.01
Parameter values
Significance of dose response
p-value for B being significantly different from zero