Using f2 for compounds that never reach 85% dissolution [Dissolution / BCS / IVIVC]

posted by Dr_Dan  – Germany, 2017-01-16 19:10 (2944 d 12:18 ago) – Posting: # 16959
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Dear wligtenberg
I am not experienced in this field, but if I look at EMA/CHMP/806058/2009/Rev. 02 see and take this analogously for products for ocular use I would ask you if it is really necessary to calculate f2 values in order to demonstrate similarity between the test liposomal product and the reference? Wouldn’t it be sufficient just to show the figures? According to this reflection paper IMHO you just need to address (among many others)I hope this helps

Kind regards and have a nice day
Dr_Dan

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