Validating methods

Traditional measures of analytical goodness include the following: This strategy has its advantages and its drawbacks.The advantage is the lab can develop and evaluate the goodness of a method independent of the product and the associated acceptance criteria it is intended to measure.Effectively the question is: how much of the specification tolerance is consumed by the analytical method?Finally, how does the method contribute to OOS events when releasing product to the clinic or market?Further, the traditional approach will often falsely indicate a method is performing poorly at low concentrations, when in fact it is performing excellently.Conversely, at high concentrations, the method will often appear to be performing well—as the % CV and % recovery appear to be acceptable—when it is actually unacceptable relative to the product specification limits it will be used to evaluate.Analytical method accuracy/bias and precision are always in the path of drug evaluation and associated acceptance/failure in release testing.

Speakers featured in the 2013 UW ICTR Short Course were originally part of the 2012 Training Institute for the Dissemination and Implementation of Research in Health (TIDIRH).Video capture & materials from the 20 TIDIRH Institutes are below.This [email protected] course is geared to the novice qualitative researcher.Methods with excessive error will directly impact product acceptance out-of-specification (OOS) rates and provide misleading information regarding product quality.Historically, analytical chemists have worked on the science of an analytical method and maintained their evaluations of method goodness independent from the product they intend to evaluate.

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