Dissolution and bracketing [Regulatives / Guidelines]
❝ Can bracketing be used for additional strengths were the dissolution is not similar? Could BE-studies been done on the highest and lowest strength and not on middle strengths in this case?
Bracketing approach (when deviation from biowaiver criteria exist ) for additional strength Biowaivers is allowed according to both EMA and FDA but they differ in the principle for selecting the strengthes for which the 2 BE studies should be performed.
For EMA: Strengths selected must represent the extreme of deviation(s) from biowaiver conditions:-
Proportionality of strengths
Similarity of dissolution
Linearity of pharmacokinetics (under fasted and/or fed administration)
i.e in your case the two strength which differ in Similarity of dissolution and ( proportionality or PK linearity)
For FDA : The 2 BE-studies must be done on the highest and lowest strengthes.
- Dissolution and bracketing - EMA Susanh 2020-03-19 18:39 [Regulatives / Guidelines]