How it works
ICH Q2(R2) asks for at least five concentration levels across the range, with the regression line, correlation coefficient, y-intercept and residual sum of squares reported. A high r² alone does not prove linearity: look at the residuals and the back-calculated accuracy at each level.
When the variance grows with concentration, as it usually does over the wide ranges of bioanalytical methods, weighted regression (1/x or 1/x²) stops the top standards dominating the fit and gives better accuracy at the low end. ICH M10 requires back-calculated standards within ±15% of nominal (±20% at the LLOQ).