CROSS-VALIDATION OF BIOANALYTICAL METHODS BETWEEN LABORATORIES

Increased reliance on pharmacokinetic studies in regulatory submission s emphasizes the need for cross-validating bioanalytical methods betwe en different laboratories to allow comparison of data. Globalization o f pharmaceutical development results in a greater need to define cross -validation standards. A strategy for performing cross-validation expe riments using prepared biological samples of known concentration and ' 'real'' samples from clinical trials is presented. The statistical tec hniques used to compare data sets and establish acceptability of the a ssays are illustrated by practical examples.