Dissolution and bracketing [Regulatives / Guidelines]

posted by wienui  – Germany/Oman, 2020-03-21 18:39 (1049 d 19:36 ago) – Posting: # 21292
Views: 2,600

Hi Susanh,

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.

Best regards,

Cheers,
Osama

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