MR generic application [Regulatives / Guidelines]

posted by vixen – Czechia, 2020-03-23 19:40 (135 d 12:55 ago) – Posting: # 21296
Views: 1,211

Hi Mikkabel,
More details are needed to determine what we are dealing with here:
- presumably it's an application for Europe?
- is it a single or multiple unit formulation?
- what does the reference SmPC say about intake with/without food?
- is accumulation expected?
- do all three strengths meet the general biowaiver criteria per section 4.1.6 of the Guideline on the investigation of bioequivalence?
- is the shape of all three strengths similar?
- which two strengths represent the extremes? consider it separately for each of the factors listed by section 6.6. of EMA MR Guideline.

Are you familiar with Annex IV to the EMA Guideline on the pharmacokinetic and clinical evaluation of modified release dosage forms?

Cheers,
vixen

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