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Registerf2 computation (for pts > 85%) [Dissolution / BCS / IVIVC]
» 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.
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.
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Complete thread:
- f2 computation (for pts > 85%) jag009 2018-09-10 18:41 [Dissolution / BCS / IVIVC]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- f2 computation (for pts > 85%) ElMaestro 2018-09-10 22:52
- f2 computation (for pts > 85%) jag009 2018-09-12 00:00
- f2 computation (for pts > 85%)Obinoscopy 2018-09-11 20:21
- f2 computation (for pts > 85%) jag009 2018-09-12 00:01
- f2 computation (for pts > 85%) - WHO GL Obinoscopy 2018-09-12 00:38
- f2 computation (for pts > 85%) - WHO GL Helmut 2018-09-12 01:01
- f2 computation (for pts > 85%) - WHO GL jag009 2018-09-12 20:35
- f2 computation (for pts > 85%) - WHO GL ElMaestro 2018-09-12 22:02
- f2 computation (for pts > 85%) - WHO GL Obinoscopy 2018-09-12 00:38
- f2 computation (for pts > 85%) jag009 2018-09-12 00:01
- f2 computation (for pts > 85%) ElMaestro 2018-09-10 22:52
Ing. Helmut Schütz