f2 computation (for pts > 85%) [Dissolution / BCS / IVIVC]

posted by Obinoscopy  – USA, 2018-09-11 20:21 (771 d 06:07 ago) – Posting: # 19260
Views: 3,228

» One question related to f2 computation... According to guidance you only include one pt after 85 % release.

Yes.

» But for drugs that don't show plateau after 85% (ie; even at one pt after 85%, the curve is still climbing) you have to include addition points right?

I don't think so. Once 85% dissolution has been achieved, then we can calculate for f2.

Was told 85% is a sacred clinical number (don't ask who told me ;-)). Was told once 85% of a drug dissolves within the expected time the drug gets to the intestine, then it is very bioavailable. Whatever happens beyond the 85% is just additional info which isn't critical.

Based on this, I think 85% is the determinant. Only if 85% is not achieved then we now check when plateau is reached.

Not sure though. Perhaps I'm mixing up biowaivers dissolution with other form of dissolution studies.

Scopy

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