f2 comparison [Dissolution / BCS / IVIVC]
Hi,
A question... If two products achieve release ≫85% at the 2nd timepoint, do i still need to calculate f2 since f2 requires a minimum of 3 points and only 1 value above 85% can be included?
Please see below, at 2nd timepoint it's already ≫85%. I know that f2 is not required if release >85% within 15 mins but the lab only recorded release at 20 mins. It's safe to assume that >85% was probably achieved by 15 mins but i have no data to support.
Test at 10 mins=42%, at 20 mins=92%, at 30 mins=97%
RLD at 10 mins=43%, at 20 mins=92%, at 30 mins=98%
Thanks
J
A question... If two products achieve release ≫85% at the 2nd timepoint, do i still need to calculate f2 since f2 requires a minimum of 3 points and only 1 value above 85% can be included?
Please see below, at 2nd timepoint it's already ≫85%. I know that f2 is not required if release >85% within 15 mins but the lab only recorded release at 20 mins. It's safe to assume that >85% was probably achieved by 15 mins but i have no data to support.
Test at 10 mins=42%, at 20 mins=92%, at 30 mins=97%
RLD at 10 mins=43%, at 20 mins=92%, at 30 mins=98%
Thanks
J
Complete thread:
- f2 comparisonjag009 2018-04-10 15:58 [Dissolution / BCS / IVIVC]
- f2 comparison wienui 2018-04-10 17:39
- f2 comparison Vineeth KE 2018-04-12 08:31
- f2 comparison wienui 2018-04-12 10:14
- f2 comparison Yura 2018-04-12 14:13
- f2 comparison wienui 2018-04-12 17:38
- f2 comparison Yura 2018-04-13 07:48
- f2 comparison wienui 2018-04-12 17:38
- f2 comparison Yura 2018-04-12 14:13
- f2 comparison wienui 2018-04-12 10:14
- f2 comparison jag009 2018-04-12 17:10