BioOutsource — cGMP compliant biotesting
Parallelism
The European Pharmacopeia (EP) (5.3. Statistical Analysis of Results of Biological Assays and Tests) states that:
"The reference and sample should be interpretable as a dilution assay"
That is, the sample should behave as though it were a dilution of the reference. If this is the case, the dose response curve of the sample will be parallel to the dose response curve of the reference material. BioOutsource can provide advice on the most appropriate method of parallel determination and definition of acceptance criteria for your assay.
