Bioequivalence and Bioavailability Forum • Russia BE Study

Russia BE Study [Regulatives / Guidelines]

posted by Beholder – Russia, 2020-10-03 21:51 (2093 d 04:21 ago) – Posting: # 21967
Views: 6,416

Hi Brus!

An idea visited my mind. The permission for clinical trial in Russia does not contain the information regarding analytical/PK part of the study at all. It talks only about clinical part of BEQ project. So in Russia we can say that clinical study = clical part of BEQ study. So it means that only clinical part has to be conducted in Russia. Again indirect prove but only this we have. Hope it helps.

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Best regards
Beholder

Complete thread:

Russia BE Study Anand 2015-03-27 05:28
- Russia BE Study Beholder 2015-03-27 09:46
  - Russia BE Study Anand 2015-03-27 10:24
    - Russia BE Study Beholder 2015-03-27 12:21
      - Red Book? Helmut 2015-03-27 14:16
        
        Red Book? Yeah... Beholder 2015-03-29 16:36
        
        Red Book? Yeah... Alyssa 2020-10-05 06:00
        
        Red Book? Yeah... Beholder 2020-10-05 11:34
  - Russia BE Study Brus 2020-10-01 16:05
    - Russia BE Study Helmut 2020-10-01 16:47
      - Russia BE Study Brus 2020-10-01 16:51
        
        Russia BE Study Helmut 2020-10-01 17:02
        
        Russia BE Study Beholder 2020-10-02 09:24
    - Russia BE StudyBeholder 2020-10-03 19:51
      - Russia BE Study Brus 2020-10-21 10:42
- Russia BE guidelines Ohlbe 2015-03-27 09:52