Bioequivalence and Bioavailability Forum

Beware of Add-on Studies! [Study As­sess­ment]

posted by Shuanghe  – Spain, 2013-05-27 17:59 (4779 d 15:29 ago) – Posting: # 10666
Views: 16,653

Hi Helmut,

❝ It doesn’t make sense to plan for BE of AUC (CV 41%) since you will fail with C_max (CV 65%).

From the Xipei's habit of estimating sample size with AUC I assume this is a study for Chinese regulation. If so, the Chinese BE guideline reads that criterion for AUC is 80-125 but for Cmax, hold-on, deep breath, …, 70-143% (and the study doesn't even have to be of replicate design )

OK, now you can pick the draw you just dropped on the ground.

Complete thread:

• Add more subjects after a failed BE study of a HVD wxp 2013-05-27 10:34 
  • bad luck Dr_Dan 2013-05-27 12:28
    • bad luck wxp 2013-05-27 14:19
  • Beware of Add-on Studies! Helmut 2013-05-27 13:51
    • Beware of Add-on Studies!Shuanghe 2013-05-27 15:59
      • Oh wow! Helmut 2013-05-27 16:21
        • The same criterion of Cmax in China now wxp 2013-05-28 06:10
          • SFDA ⇒ CFDA Helmut 2013-05-28 13:02
            • Helmut, updated Chinese BE guideline here Shuanghe 2013-06-14 11:05
              • BE in Chinese Pharmacopoeia Helmut 2013-06-14 14:22
                • BE in Chinese Pharmacopoeia Shuanghe 2013-06-14 14:56
                  • BE in Chinese Pharmacopoeia Helmut 2013-06-14 16:11
    • Add more subjects after a failed BE study of a HVD wxp 2013-05-28 05:13
      • Still many subjects… Helmut 2013-05-28 12:56