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

posted by Obinoscopy  – USA, 2018-09-11 20:21 (1437 d 12:57 ago) – Posting: # 19260
Views: 4,115

» 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

Complete thread:

UA Flag
Activity
 Admin contact
22,305 posts in 4,668 threads, 1,587 registered users;
online 9 (1 registered, 8 guests [including 1 identified bots]).
Forum time: Friday 09:18 CEST (Europe/Vienna)

Doctors are men who prescribe medicines of which they know little,
to cure diseases of which they know less,
in human beings of whom they know nothing.    Voltaire

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5