Bioequivalence and Bioavailability Forum • Russian guideline(s)

Russian guideline(s) [Regulatives / Guidelines]

posted by Vasily – Moscow, 2012-03-15 13:50 (5220 d 04:14 ago) – Posting: # 8276
Views: 4,508

Dear HS,

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

Regards,

Vasily

—
Sincerely,

Vasily

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