Bioequivalence and Bioavailability Forum

Hi Vandee & Ohlbe,

As Ohlbe said, according to EMA for an additional strength biowaiver, the Amount of API(s) must be < 5% of tablet (capsule) core weight for both strengths, the BE strength and the biowaiver one.
Moreover, the Amounts of excipients are the same per strength or Only the amount of a filler is changed to account for changes in API weight.

The FDA doesn't consider this 5% rule and the requirements for an additional strength biowaiver are as following:

• Total weight of dosage form nearly the same for all strengths
  
• Same inactive ingredients in each strength
  
• Change in strength obtained by varying active and one or more inactive ingredients

Both EMA & FDA are asking for the Similarity of dissolution characteristics of the biowaiver strength to the strength for which bioequivalence has been demonstrated in vivo.


I hope this could help.