Sample after >85% release [Dissolution / BCS / IVIVC]

posted by wienui  – Germany/Oman, 2018-04-27 03:23 (1565 d 19:40 ago) – Posting: # 18736
Views: 9,310

Dear Scopy,

» For the second scenario, I thought it should be till 15 mins for WHO and till 30 mins for FDA and EMA. This because the time point for the comparator at 15 mins was 88% while the time point for the test product at 30 mins was 89%. These were the points when >85% was first achieved. Please confirm if I'm right.

1 time point have to be added in the calculation of f2 after reaching the 85% releasing time point, i.e
WHO: 20 min
EMA & FDA: 45



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