Dissolution and bracketing [Regulatives / Guidelines]
Just to make sure I’m understanding correctly:
- I have generic IR product for EU submission
- There are 5 strengths that are dose proportional
- All the General biowaiver criteria are fulfilled except the f2 similarity is not achieved between the highest strength (used in BE study) and the lower strengths
Do I need to do a BE study on all the strengths that are not showing similarity in dissolution
Can I use bracketing approach and just add one study, either on the lowest strength or the strength differing most in dissolution?
Thanks for your help.
- Dissolution and bracketing - EMA Susanh 2020-03-19 18:39 [Regulatives / Guidelines]