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

posted by jag009  – NJ, 2018-09-12 20:35 (862 d 05:59 ago) – Posting: # 19280
Views: 3,173

Hi,
» I don't know what the USFDA GLs say though.
» I guess person who told you has a lot of explaining to do. I for one, am very interested in his explanation.

But if you do end up computing f2 using all pts? What's the harm in that? Isn't it better to conclude based on a complete profile? (meaning stop when plateau is evident. Of course this term plateau is kinda of objective.

Example:
Time: 1,2,3,4,6,8,10,12
R: 27,42,54,62,76,86,92,96
T: 34,51,64,73,87,94,98,99

If we go by the definition out there then you would cut off at 8 hours. But if you compute f2s at 8 hrs cutoff vs 12 hrs then the 8 hr cutoff f2 will fail (<50). At 8 hrs the profile isn't really complete (visually).

Thank
John

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