Bioequivalence and Bioavailability Forum

Russia: Toxicity data required [Regulatives / Guidelines]

posted by Karthikeyan – India, 2013-09-03 10:48 (4677 d 00:53 ago) – Posting: # 11412
Views: 11,920

Dear Mittyri,

❝ According to this draft it will be allowed only to post a literature review of originator's preclinical trials.

I understand that earlier we need to go for toxicity studies for generics and now the current draft tell to provide literature review of the product.

is my understanding is correct. Please correct me if i'm wrong.

Regards,

Karthikeyan

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 required Helmut 2013-09-02 10:31
        • Russia: Toxicity data required mittyri 2013-09-02 14:18
          • Russia: Toxicity data requiredKarthikeyan 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