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

posted by jag009  – NJ, 2018-09-12 02:00 (2132 d 01:07 ago) – Posting: # 19262
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❝ ❝ 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:


NOT me! My boss said so... I was wondering too.
Does it matter if the drug is an ER or IR?

Thx
John

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