Bioequivalence and Bioavailability Forum

❝ stupid question. Sometimes I feel I’m lacking the most basic skills. EMA’s GL states:

The concentration obtained for the initial analysis and the concentration obtained by reanalysis should be within 20% of their mean for at least 67% of the repeats.

❝   1st     2nd     x      ∆2-1    |∆ (% x)|

❝ 40.303  42.333  41.318  +2.030     4.91

❝ Have we been too stringent?

❝ Does EMA expect instead:

❝   1st     2nd     x      ∆1-x    ∆2-x    ∆1 (% x)  ∆2 (% x)  |∆1,2 (% x)|

❝ 40.303  42.333  41.318  -1.015  +1.015   -2.46     +2.46        2.46