Insights · Free tool

ISR calculator (ICH M10)

Work out how many incurred samples to repeat, and evaluate your original and repeat results against the ICH M10 rule. Everything runs in your browser - no data leaves your computer.

1. How many ISR samples?

Number of study samples

Enter the number of study samples.

10% of the first 1,000 samples plus 5% of the samples above 1,000.

2. Evaluate the results

Method type

Paste original and repeat results - one pair per line (from Excel: two columns; an optional sample ID first)

The calculator needs JavaScript. The formula: % difference = (repeat − original) / mean × 100; at least two-thirds of the pairs must be within ±20% (±30% for ligand-binding assays).

For education and cross-checking. Results are not a validated GxP record; in regulated work use your validated system and SOPs. Read the ISR guide →

ARISENTO Insights is published by Autofai Technologies Private Limited, the makers of ARISENTO bioanalytical software.