Bioequivalence and Bioavailability Forum • BE in Chinese Pharmacopoeia

BE in Chinese Pharmacopoeia [Study Assessment]

posted by Helmut – Vienna, Austria, 2013-06-14 18:11 (4756 d 09:24 ago) – Posting: # 10798
Views: 16,205

Hi Shuanghe!

❝ […] but from the context I'd say that they are asking for the observed.

Correct. I is not clear to me whether the observed C_tn is mandatory to be used.

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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 PharmacopoeiaHelmut 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

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