Bioequivalence and Bioavailability Forum • Some questions from EGA regarding MR Guideline

Some questions from EGA regarding MR Guideline [Regulatives / Guidelines]

posted by mittyri – Russia, 2016-08-26 19:43 (3593 d 12:53 ago) – Posting: # 16593
Views: 7,425

Hi Helmut,

I've found a presentation released by European Generic and Biosimilar Medicines Association.
I suppose you are familiar with it.

They are asking very interesting questions, regarding waiving MD too. Could you please comment their questions?
At least this one:

Accumulation, i.e. AUC_0-τ steady state / AUC_0-τ after first administration is

11% with the current 90% criterion
25% with an 80% criterion

For linearity assessment, a ±25% difference in AUC is acceptable.

We would like to get clarification regarding the rationale behind the 90% criterion.

—
Kind regards,
Mittyri

Complete thread:

multiple dosage study Mahesh M 2016-08-18 12:50
- 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 Guidelinemittyri 2016-08-26 17:43
        
        Quod licet Iovi, non licet bovi Helmut 2016-08-26 19:42