Bioequivalence and Bioavailability Forum

Toxicity data: why? [Regulatives / Guidelines]

posted by Helmut  – Vienna, Austria, 2013-09-03 15:02 (4676 d 21:24 ago) – Posting: # 11416
Views: 11,936

Hi Miityri,

❝ Are new requirements in this draft (see above) closer to EMEA GL?

Since EMA doesn’t require anything – yes, closer.

I still fail to understand this requirement at all. Animal models are – only models. The innovator’s drug is on the market for years – administered to humans (the target species), not animals (a model species). Pharmacovigilance data show that the drug is safe or – more precisely – its benefits outweigh its risks. These safety data are available to regulators. It is beyond my intellectual reach how short term toxicity data in say 24 Sprague Dawley rats could give more information than ADRs collected in millions of patient-years.

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна! 
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 required Helmut 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