Bioequivalence and Bioavailability Forum

ги́бкость [Regulatives / Guidelines]

posted by Helmut  – Vienna, Austria, 2013-09-03 23:16 (4676 d 09:45 ago) – Posting: # 11421
Views: 11,896

Hi Dan,

❝ Does anybody have experience with Russian authorities?

A little bit. I know one of the scientific advisors responsible for the BE guidance. Very knowledgable person, mathematical statistician, and specialised in Population PK.

❝ I never met anybody who submitted a dossier but there are a some people who like to discuss what would happen if......

❝ Out of curiosity: have you ever tried to find a phase I CRO in Russia?

Not personally but I know one company succeeding. Took them two years, opening up an office in Moscow, a lot of site visits, mock-up inspections, and trainings. The clinical phase of the first study ran last autumn.

❝ I could not identify one site which could conduct bioequivalence studies in a way we are used to it.

Define “the way you are used to it”. An important term in Russia is “flexibility” – which has a long and valuable tradition.

• If the axis of Mr Putin’s truck breaks in the middle of a snowstorm in Siberia he gets out the welding equipment and fixes it. Mr Obama would just sit there, complain that his mobile gets no connection, and freeze his butt off.
  
• The Мир space station was in orbit for 15 years – at its end of service more or less sticked together by duct tape, cable ties, and twine. Cosmonauts enjoyed the space toilet developed in the СССР at a time where astronauts had still to face a future of shitting in diapers for years to come.

As you see from these examples this tradition of flexibility sits deep and you can expect to receive surprised looks when talking about the formalisms of GxP.

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


The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

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
        • ги́бкостьHelmut 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