As per ICH guideline Q2(R1)
LOD =( 3.3 * Std. dev. of response) / Slope of calibration curve
LOQ =( 10 * Std. dev. of response) / Slope of calibration curve
Please explain the methodology.
Which calibration curve is to be used to get slope, is the linearity curve or any other?
Again 6.3.3 & 7.3.3 talks about a specific calibration curve for sample in the range of DL & QL respectively. In that what is residual std. dev. of regression line or std. dev. of y-intercepts of regression lines may be used as std. dev.
I did'nt understand it?