Bioequivalence and Bioavailability Forum • BE with 1 not included in CI -danish twist

BE with 1 not included in CI -danish twist [RSABE / ABEL]

posted by bjkim97 – Korea / Seoul, 2013-02-06 06:56 (4888 d 14:14 ago) – Posting: # 9969
Views: 6,551

❝ Dear d_labes!

❝ If your study is aimed for the European market no go! The widest acceptance range allowed in the EMA guidance is 69.84% ... 143.19% given that your study is a replicate crossover study and your intra-subject CV of the Reference from that study is >=50%. Note that the widening is only allowed for Cmax.

Why this CV(Intra) is >=50%?
Is this CV(Intra)>=30%?. Is not that widening is more than >=30%?

Complete thread:

BE with 1 not included in CI ? Coja66 2013-01-16 10:12
- BE with 1 not included in CI ? ElMaestro 2013-01-16 11:38
  - BE with 1 not included in CI -danish twist d_labes 2013-01-16 15:07
    - BE with 1 not included in CI -danish twist ElMaestro 2013-01-16 17:46
      - BE with 1 not included in CI -danish twist The Outlaw Torn 2013-01-17 13:27
    - BE with 1 not included in CI -danish twistbjkim97 2013-02-06 05:56
      - EMA widenend ABEL d_labes 2013-02-06 09:27