Bioequivalence and Bioavailability Forum

bad luck [Study As­sess­ment]

posted by wxp  – China, 2013-05-27 16:19 (4772 d 10:02 ago) – Posting: # 10664
Views: 16,515

❝ a BE study is a pivotal study and so unfortunately it will not be possible to add another group of subjects since this has to be pre-specified in the protocol. ...

Thank you, Dr_Dan!

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 luckwxp 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