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

posted by wienui  – Germany/Oman, 2018-04-22 21:39 (1576 d 18:09 ago) – Posting: # 18720
Views: 9,623

Hi Scopy & Helmut,

» » […] a situation where a test product is rapidly dissolving (>85% in 30 mins) while the comparator product is very rapidly dissolving (>85% in 15 mins) and vice versa. Is f2 calculation necessary? If it is, which time points will be used?

I think in this case a calculation of f2 is necessary, as the condition for not required calculation of f2 is not exist.

when both test and reference products dissolve 85 percent or more of the label amount of the drug in 15 minutes using all three dissolution media recommended above, the profile comparison with an f2 test is unnecessary.

The differences in the GL's as mentioned in the reply of Helmut concerned how and when an additional time point after reaching the 85% release amount can be included in the calculation.

As not more than 1 time point is allowed to be added in the calculation of f2 after reaching the 85% releasing time point (can be at time points 45min, 60min, ...).
Best regards,

Osama

Cheers,
Osama

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