(607 d 15:00 ago)
Posting: # 22487
According to the Guideline on the pharmacokinetic and clinical evaluation of modified release dosage forms EMA/CHMP/EWP/280/96 Rev1.
If the reference SmPC recommends intake under fed conditions, one single dose bioequivalence study at the highest/most sensitive strength conducted in fasting state may be sufficient. The other strength(s) can be waived if the criteria described for waiver of strength described in section 4.1.6 of the Guideline on the investigation of bioequivalence (CPMP/EWP/QWP/1401/98) are fulfilled.
However, if the strengths of the test product do not fulfil these criteria or if the different strengths have different shape two strengths representing the most extreme difference should be tested in fasting state.
My questions are:
Edit: Guidelines linked. [Helmut]
(601 d 18:48 ago)
Posting: # 22512
❝ 1. Does the term shape is referring to the shape of the dissolution curve or to the shape of the dosage form (shape of the tbl.)?
The latter. The EMA is concerned about the surface area/volume ratio potentially influencing PK. See this presentation of Henrike Potthast (EUFEPS workshop, Bonn, June 2013).
❝ 2. if there is deviation from quantitatively proportional composition and requirements for biowaiver set in the Guideline CPMP/EWP/QWP/1401/98 are fulfilled. Is it sufficient to demonstrate similarity based on f2 factor only or still the shape of the tablets should be the same in order to use biowaiver approach and waive BE study?
Sorry, no idea…
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