This application simulates the effects of different parameters on the validity of a potency assay based on the USP 1033 guideline as explained here. The What if? section below allows to adjust product specifications, risk of measuring outside these specifications, production process, procedure parameters, and to see the effect on final measurement performance. This allows the analyst to determine which part of the process is most beneficial for improvement. Out-of-specification probability is the maximal allowed probability to measure values outside of product lower and upper specification limits during routine use. The original assay performance data, Level (RP), Relative Bias (RB) and Intermediate Precision (IP) are the same as in the USP 1033 example but can be adjusted (by double-clicking) to see the effect on the final performance.

For a more advanced implementation based on tolerance intervals, probability to correctly detect true defects, or generic assays based on the ICH Q2(R2) guideline, or general questions, please send a mail to info@rovad.be.