Template for calculating the trueness in method validations

In case analytical methods are evaluated for their suitability, the parameter "trueness" must also be considered during method validation for quantitative analyses of impurities as well as for content determinations and potency assays according to the method validation guideline ICH Q2(R1).

The Excel template provided for download is intended to facilitate the evaluation after completion of the experiments and considers different evaluation options, such as spiking (if impurities are present) or, if no impurities are present for spiking, inferring trueness from linearity data and determining the recovery or, after normalization, calculating the RSD for purity determinations. For content determinations and potency tests, the "spiking approach" can also be used, of course without addition of the spike ????

As with the previous templates for linearity and precision, this template again includes a practical example for illustration, in addition to the blank template for entering the raw data. Finally, we would like to emphasize that this template has been created to the best of our knowledge and is primarily intended to show possible calculation pathways and therefore has not been csv validated.

 

Template for the evaluation of trueness

 

Further calculation templates for other method validation parameters are planned and will follow successively.