TrueGate Bio

Analytics tools you can use right now

Working calculators for the questions that come up in regulated labs: do two methods agree, how many samples you need, what a spot-check proves, and how long a product stays in specification.

Working calculators, running entirely in your browser. Nothing you enter leaves this page. Each one is a small version of analysis TrueGate Bio does on real programs. For decisions that matter, have the analysis reviewed against your protocol and SOPs.

Method comparison: Passing-Bablok and Bland-Altman

Bridging two methods or two instruments? Passing-Bablok regression separates constant bias (intercept) from proportional bias (slope) and tolerates error in both methods. Bland-Altman shows agreement and its limits. Paste paired results as two columns (method A, method B), one pair per line.

Run the analysis to see results.

Sample size and power

How many samples does a comparison need before a null result means anything? Set the difference you need to detect and your tolerance for false positives and false negatives.

Enter values and calculate.

Spot-check confidence

You reviewed a sample of records (redactions, batch records, data entries) and found some defects. What can you honestly claim about the whole set? Uses the exact binomial (Clopper-Pearson) upper bound; with zero defects it reduces to the rule of three.

Enter values and calculate.

Stability shelf-life estimate

Linear regression of an attribute over time with a one-sided 95% confidence bound on the mean, following the approach in ICH Q1E for a single batch. Shelf life is where the bound meets the specification. Paste time and value pairs, one per line.

Run the estimate to see results.