MR: Different shapes [Dissolution / BCS / IVIVC]
❝ 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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