Bioequivalence and Bioavailability Forum

Method not sensitive enough [Study Assessment]

posted by Helmut – Vienna, Austria, 2019-12-18 16:16 (1762 d 22:18 ago) – Posting: # 20993
Views: 4,201

Hi Aymanmy,

the requirement of LLOQ ≤ 5% of C_max is used to assess carry-over. For the future: Never develop an analytical method based on an average C_max. 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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Helmut Schütz

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Complete thread:

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
  - Revalidation? mittyri 2019-12-18 16:52
    - Revalidation? Helmut 2019-12-18 17:40
  - Method not sensitive enough Aymanmy 2019-12-18 17:58
    - Method not sensitive enough Helmut 2019-12-18 18:54
      - Method not sensitive enough Aymanmy 2019-12-19 08:21

Method not sensitive enough [Study As­sess­ment]

Complete thread:

Method not sensitive enough [Study Assessment]