FPP [Dissolution / BCS / IVIVC]

posted by JMCardot  – France, 2018-05-19 10:12 (1543 d 12:50 ago) – Posting: # 18789
Views: 8,694

Dear all

Except if I mistaken I think that the we can simplify it as follow


EMA: Not more than one mean value of > 85% dissolved for any of the formulations.
FDA: Only one measurement should be considered after 85 percent dissolution of both products.

best regards,

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