Method not sensitive enough [Study As­sess­ment]

posted by Helmut Homepage – Vienna, Austria, 2019-12-18 15:16 (309 d 07:08 ago) – Posting: # 20993
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Hi Aymanmy,

the requirement of LLOQ ≤ 5% of Cmax is used to assess carry-over. For the future: Never develop an analytical method based on an average Cmax. Since to have to comply for all subjects in all periods plan for the worst case (i.e., subjects with the lowest concentrations). This is particularly important for drugs with high between-subject variability.

» […] no detected concentrations in the predose samples for these subjects.

Yep but the method was not sensitive enough for these subjects. Hence, I support Dan’s suggestion (exclude the subjects and check whether you still pass BE).

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