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

posted by mittyri – Russia, 2016-08-26 19:43 (3089 d 05:45 ago) – Posting: # 16593
Views: 6,121

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. AUC0-τ steady state / AUC0-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

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