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Dabigatran EMA - product-specific guide [Regulatives / Guidelines]

posted by nobody - 2019-02-14 13:34  - Posting: # 19918
Views: 209

» Highly variable in fasted but not in fed state.

Hm, here we talk about solubility over relevant pH range. Only good solubility in acidic range, but... see Samant, 2018 on ribociclib. Solubility in aqueous media is only half the story.

» Aren’t you notoriously shouting “It’s the originator, stupid…”?

Could you elaborate on this. No clue what this might mean. If you want a duel, choose your weapon

» I’m more concerned about the first footnote in the guidance

* As intra-subject variability of the reference product has not been reviewed to elaborate this product-specific bioequivalence guideline, it is not possible to recommend at this stage the use of a replicate design to demonstrate high intra-subject variability and widen the acceptance range of Cmax. If high intra-individual variability (CVintra > 30 %) is expected, the applicants might follow respective guideline recommendations.

meaning that one can plan for the EMA’s method of reference-scaling. Was the EMA’s PKWP not aware of the the FDA’s guidance?

Narrow therapeutic range... maybe in the USA. In the EU there are no mass tort trials...

What buys you the widening for Cmax, when both parameters are highly variable? :confused:

Kindest regards, nobody

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