Bioequivalence and Bioavailability Forum • Russia: Toxicity data required

Russia: Toxicity data required [Regulatives / Guidelines]

posted by Helmut – Vienna, Austria, 2013-09-02 12:31 (4682 d 19:26 ago) – Posting: # 11404
Views: 12,127

Hi Karthikeyan,

❝ i am in need of information, whether that is sufficient or we need additional toxicity or clinical trials...

You need toxicity data of the formulations (test + reference!) – not only of the API – before you start a BE study. The idea behind is a complete mystery to me. Anyhow, according to federal law #61 (aka “Lex Putin”) BE studies have to be performed by Russians CROs only. AFAIK, no way to do it in India.

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Helmut Schütz

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Complete thread:

Russia Guidance – BE Karthikeyan 2013-09-02 05:55
- Russia Guidance – BE drgunasakaran1 2013-09-02 06:14
  - Russia Guidance – BE Karthikeyan 2013-09-02 06:21
    - Russia: Toxicity data requiredHelmut 2013-09-02 10:31
      - Russia: Toxicity data required mittyri 2013-09-02 14:18
        
        Russia: Toxicity data required Karthikeyan 2013-09-03 08:48
        
        Russia: Toxicity data required mittyri 2013-09-03 09:26
        
        Toxicity data: why? Helmut 2013-09-03 13:02
        Russia: Toxicity data required Karthikeyan 2013-09-04 06:46
        
        Russia: Toxicity data required mittyri 2013-09-04 08:58
        
        Federal Law # 61–FZ “On circulation of drugs” Helmut 2013-09-05 00:09
        
        Federal Law # 61–FZ “On circulation of drugs” Karthikeyan 2013-09-05 13:52
        
        # 61–FZ adopted 24 March 2010 Helmut 2013-09-05 15:21
        
        # 61–FZ adopted 24 March 2010 Karthikeyan 2013-09-06 06:32
        
        # 61–FZ adopted 24 March 2010 mittyri 2013-09-06 07:22
- Russia Guidance – BE Dr_Dan 2013-09-03 14:40
  - Russia Guidance – BE Helmut 2013-09-03 14:45
    - Russia Guidance – BE Dr_Dan 2013-09-03 19:27
      - ги́бкость Helmut 2013-09-03 21:16
        
        Flexibility Dr_Dan 2013-09-04 10:20
        
        Cultural ∆ Helmut 2013-09-04 14:30
      - Russia Guidance – BE mittyri 2013-09-04 09:15