Method not sensitive enough [Study Assessment]
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).
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
The quality of responses received is directly proportional to the quality of the question asked. 🚮
- BEQ inquiry from health authority Aymanmy 2019-12-18 08:51 [Study Assessment]
- BEQ inquiry from health authority Dr_Dan 2019-12-18 14:46
- Method not sensitive enoughHelmut 2019-12-18 15:16