Some questions from EGA regarding MR Guideline [Regulatives / Guidelines]
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:
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
Kind regards,
Mittyri
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 Guidelinemittyri 2016-08-26 17:43
- Quod licet Iovi, non licet bovi Helmut 2016-08-26 19:42
- τ in SD = intended dosage interval Helmut 2016-08-26 11:08
- multiple dosage study Mahesh M 2016-08-25 09:36
- multiple dosage study VStus 2016-08-24 21:37