Similarity testing is the new approach to prove the validity of your bioassay. In similarity testing, you compare regression parameters, differences of parameters or ratios or parameters along with their confidence intervals to equivalence margins. If the confidence interval falls completely into the range of the equivalence margins, the test is passed.
The challenge of this type of testing is the development of suitable equivalence margins. The Equivalence Margin Development document type of PLA 3.0 allows you to calculate candidate equivalence margins from historic assay data.
PLA 3.0 Supports These Similarity Tests
Please note: not all tests are available with every regression model.
All regression parameters can be tested as
- absolute parameter tests
- difference of parameter tests
- ratios of parameter tests
- scaled ratio of parameter tests
- tests of asymptote ranges
- tests of asymptote ratio
- scaled ratio of asymptotes
are available as well.