AN ANALYSIS OF THE WASHINGTON CONFERENCE REPORT ON BIOANALYTICAL METHOD VALIDATION

The Washington Conference Report on bioanalytical method validation is analysed with respect to the requirements for precision and accuracy. It is shown that if the requirements are interpreted too literally, t his could lead to disappointment in practice. A better approach is to separate the total measurement error into its constant (bias) and rand om (precision) components. To ensure that 95% of all methods fall with in the acceptance interval of +/-15% around the true value, would requ ire, for example, the bias to be less than or equal to 8% and the meth od precision to be less than or equal to 8% relative standard deviatio n (RSD; n = 5).