After we’ve already provided a template of a method validation plan for an identification method, we now like to share a template for a validation plan for an assay. Assays include content and potency determinations.

In case a method (that is intended to be used for quality control of drugs in the future) is to be (re-) validated in a pharmaceutical laboratory, a plan for method validation is required. The regulatory requirements such as the ICH Q2(R1) must be taken into account. A clearly structured and understandable format of a validation plan facilitates the execution of the validation of the analytical method.

Some time ago, in response to an older blog article "How to determine the LOD using the calibration curve?", I received a request on how to determine trueness and precision at the limit of quantitation (LOQ) during method validations for drugs.

In today's blog article we’d like to deal with the role and application of confidence intervals during method validations.