Choose the question you need to answer
Start with the scientific decision in front of you: fit a curve, compare a reference and test sample, map a plate, investigate assay performance, or plan validation evidence.
Statistical choices and acceptance limits must be defined for the assay and its intended use. Worked values illustrate the calculations and controls; they are not universal criteria or a substitute for an approved analytical procedure.
- Curve fitting: 4PL, 5PL, EC50, IC50, calibration, and diagnostics.
- Relative potency: reference/test comparison, parallelism, suitability, and reporting.
- Plate data: source retention, mapping, exclusions, tidy data, and downstream exports.
- Lifecycle: method development, validation evidence, control charts, data integrity, and integration.
Check that you can reproduce the result
For each calculation, confirm the required inputs, transformations, model convention, diagnostics, and report fields. A result without this context is difficult to review, compare, or repeat.
Use the interactive 4PL and CV tools to test a concept, then follow the worked relative-potency data set from source CSV through the finished PDF report. The broader guides apply the same decisions to calibration, QC monitoring, validation, and laboratory data flows.
Frequently asked questions
Can I use the example acceptance limits for my assay?
Not automatically. Suitability limits should come from the intended use, development and validation evidence, applicable procedures, and scientific review. The example values show how configurable rules can be represented; they are not universal release criteria.
Are these resources regulatory or legal advice?
No. The regulatory guides link to primary agency material and identify practical questions to consider, but each organization remains responsible for its intended use, procedures, validation, and quality decisions.