Bioequivalence and Bioavailability Forum

Russian guideline(s) [Regulatives / Guidelines]

posted by Helmut  – Vienna, Austria, 2012-03-15 14:46 (5217 d 15:03 ago) – Posting: # 8277
Views: 4,564

Dear Vasily,

THX for your valuable insider’s information!

❝ To the best of my knowledge 2008 GLs are not cited in what you call "Lex Putin" (federal law #61) and thus can be treated only as recommendations.

Agree; guidelines are only some kind “soft law”. It always depends on the IEC’s and agency’s point of view on how strict they have to be followed.

❝ So theoretically your BE study protocol can be approved even if your sampling exceeds 200ml.

Do you have any practical experiences with higher volumes? BTW, since the guideline only mentions 2×2 cross-overs how to you deal with drugs with long-half lives or studies in patients with unstable diseases (only parallel design feasible in both cases)?

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


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Complete thread:

• Russian guideline(s) Helmut 2012-03-14 16:03 
  • Russian guideline(s) Vasily 2012-03-15 12:50
    • Russian guideline(s)Helmut 2012-03-15 13:46
      • Russian guideline(s) Vasily 2012-03-15 15:25
        • Russian guideline(s) Helmut 2012-03-15 15:46
  • Russian guideline(s) ElMaestro 2012-03-16 13:22
    • Russian guideline(s) Helmut 2012-03-16 13:44