Bioequivalence and Bioavailability Forum

Dear Members

in ICH M10 the following was mentioned at 3.3.1. Analytical run

The impact of any carry-over that occurs during study sample analysis should be assessed and reported (refer to Section 3.2.6). If carry-over is detected, its impact on the measured concentrations should be mitigated (e.g., non-randomisation of study samples, injection of blank samples after samples with an expected high concentration) or the validity of the reported concentrations should be justified in the Bioanalytical Report

Does that mean that carryover test must be done on daily bases before running study samples

thank you