Using f2 for compounds that never reach 85% dissolution [Dissolution / BCS / IVIVC]
Dear Dr_Dan,
That was a very useful document, thank you.
Although that document does not specifically state how to measure if the products are comparable, we would still need to show that they are. And I cannot imagine that eye-balling the graphs would cut it.
Still, also during development, we would like to have some idea of how different batches compare as well, so I think we would still want some kind of distance measure and a generally accepted cut-off.
But I do get from the document that you linked to, that for liposomes there are no fixed guidelines (yet).
That was a very useful document, thank you.
Although that document does not specifically state how to measure if the products are comparable, we would still need to show that they are. And I cannot imagine that eye-balling the graphs would cut it.
Still, also during development, we would like to have some idea of how different batches compare as well, so I think we would still want some kind of distance measure and a generally accepted cut-off.
But I do get from the document that you linked to, that for liposomes there are no fixed guidelines (yet).
Complete thread:
- Using f2 for compounds that never reach 85% dissolution wligtenberg 2017-01-03 15:48 [Dissolution / BCS / IVIVC]
- Using f2 for compounds that never reach 85% dissolution nobody 2017-01-03 19:19
- Using f2 for compounds that never reach 85% dissolution wligtenberg 2017-01-04 10:46
- Using f2 for compounds that never reach 85% dissolution nobody 2017-01-04 11:52
- Using f2 for compounds that never reach 85% dissolution wligtenberg 2017-01-04 10:46
- Using f2 for compounds that never reach 85% dissolution wligtenberg 2017-01-16 17:27
- Using f2 for compounds that never reach 85% dissolution Dr_Dan 2017-01-16 18:10
- Using f2 for compounds that never reach 85% dissolutionwligtenberg 2017-01-17 09:00
- Using f2 for compounds that never reach 85% dissolution Dr_Dan 2017-01-16 18:10
- Using f2 for compounds that never reach 85% dissolution nobody 2017-01-03 19:19