MR generic application [Regulatives / Guidelines]

posted by Mikkabel – Belgium, 2020-03-16 15:40  – Posting: # 21282
Views: 2,686

Dear everyone,

I have a question regarding the number of studies to be performed to get the MA for a MR formulation following a generic application.
Indeed, we are developing a generic formulation of a marketed modified release form. This MR forms is marketed with three dosages strengths X1, X2 and X3.

According to the section 6 of the Guideline on the pharmacokinetic and clinical evaluation
of modified release dosage forms (EMA/CPMP/EWP/280/96 Corr1), the following studies are required to demonstrate BE:
- a single-dose fasting study comparing test and reference drug product
- a single-dose fed study using a high-fat meal comparing test and reference drug product
- a multiple-dose study comparing test and reference drug product.

Furthermore, according to the section 6.1.2 "strength to be evaluated", the SD studies under fasting conditions should be performed for ALL strengths.

So, the question is, even if the product is eligible for the bracketing approach, is it necessary to perform the SD study with the lowest strength considering that the PK is linear for all the considered strengths?

Thanks in advance,
Best regards,

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