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Sample suitability criteria

 

4PL model

 
 
  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
Critical p-value
 
 
 
 
 
 
 
Parallelism tests for a discussion on parallelism tests see: Parallelism in Practice
 
 
 
 
Allowed range for combinations of parameters
 Range for A Difference
Upper and lower limits
 
 
 
Range for D Difference
 
 
 
 
 Range for  Normalised A Difference
 
 
 
 
Range for 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
Default p=0.01
 
 
Chi squared test
Critical P value