Differentiation of Laboratory Test Results between Abnormal and Biological Variation :

Proposal for a Reference Change Value-Based Procedure

Abstract

In a phase I clinical trial, it is essential to scientifically distinguish abnormal variation from biological variation in laboratory test results observed in healthy volunteers. However, no evidence-based standard for this has been established to date. We propose a formula that can distinguish abnormal variation from biological variations based on the Reference Change Value, which is calculated from analytical and within-subject biological variation. By using our formula, it is possible to objectively evaluate the effects of the test drug on the volunteer.