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

posted by Helmut Homepage – Vienna, Austria, 2018-04-22 16:56 (1579 d 17:58 ago) – Posting: # 18719
Views: 9,694

Hi Scopy,

» […] 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?

Tricky. ƒ2 is generally not required if product(s!) release ≥85% in all three media. In the calculation of ƒ2 the devil is in the details. There are different restrictions on samples after 85% release:Hence, bad luck for the EMA. For the FDA and the WHO, it depends.

BTW, what is an FFP?

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