MR generic application [Regulatives / Guidelines]

posted by Mikkabel – Belgium, 2020-03-27 12:03 (132 d 00:19 ago) – Posting: # 21302
Views: 668

Hi Vixen,

Thank you for your reply!

I confirm that it is an application for Europe. Regarding the product's characteristics, it is a single unit formulation that can be administrated under fasting or fed conditons and accumulation is expected. Therefore, we meet the following pattern presented in the annex IV of the guidelines on the MR dosage forms.

Strength   Single dose     Single dose   Multiple dose
           Fasting study   fed study     Fasting study
high       yes             yes           yes
middle     yes             Waiver        waiver
low        yes             Waiver        waiver


Considering that the general biowaiver are met, it allows us to perform only studies with the high and low does following the bracketing approach defined in section 6.6 of the guidelines. However, we Wonder if it would be acceptable not to perform the study with the lowest dosage considering that the Pk of the product is linear.

Cheers,
Mikkabel


Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5. Tabulators changed to spaces and BBcoded; see also this post #6[Helmut]

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