Prolonged release drug [Dissolution / BCS / IVIVC]

posted by Farmacevt – North Macedonia, 2021-07-30 17:31 (330 d 22:44 ago) – Posting: # 22487
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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:
  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.)?

  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?

Thank you

Edit: Guidelines linked. [Helmut]

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