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

posted by ElMaestro  – Belgium?, 2018-09-10 20:52 (772 d 03:33 ago) – Posting: # 19258
Views: 3,383

Hi jag,

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

Where does that concept come from? And could you put more words to it?
Also, I am thinking a plateau is something which is hard to debate in a purely measurable way.

Muy confundido :confused:

I could be wrong, but...

Best regards,
ElMaestro

No, of course you do not need to audit your CRO if it was inspected in 1968 by the agency of Crabongostan.

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