Bioequivalence and Bioavailability Forum • Quod licet Iovi, non licet bovi

Quod licet Iovi, non licet bovi [Regulatives / Guidelines]

posted by Helmut – Vienna, Austria, 2016-08-26 21:42 (2793 d 06:23 ago) – Posting: # 16594
Views: 5,782

Hi mittyri,

❝ I've found a presentation released by European Generic and Biosimilar Medicines Association.

❝ I suppose you are familiar with it.

Yes, I’ve been there.

The answer of the panelists (members of the PKWP) essentially was „We want it that way”. When reminded that MD studies are generally not required by the FDA at all (‼), 20% extrapolated AUC is the limit in Canada for many years, and we have no evidence of any problems on the other side of the pond one panelist replied „We could have required 5% as well”…

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

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Complete thread:

multiple dosage study Mahesh M 2016-08-18 12:50 [Regulatives / Guidelines]
- multiple dosage study VStus 2016-08-24 21:37
  - multiple dosage study Mahesh M 2016-08-25 09:36
    - multiple dosage study VStus 2016-08-25 18:34
  - multiple dosage study BE-proff 2016-08-26 10:45
    - τ in SD = intended dosage interval Helmut 2016-08-26 11:08
      - multiple dosage study Mahesh M 2016-08-26 14:17
      - Some questions from EGA regarding MR Guideline mittyri 2016-08-26 17:43
        
        Quod licet Iovi, non licet boviHelmut 2016-08-26 19:42