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

posted by ElMaestro  – Belgium?, 2018-09-12 20:02 (770 d 04:17 ago) – Posting: # 19281
Views: 3,092

Hi jon,

» 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.

No, actually there could be a good reason not to do that.
Consider very early and very late time points. Even if the two curves are shifted, the very early points could be close to zero dissolution, and the very late time points could close to maximum dissolution. for both. Inclusion of (many of) those points in a quantitative comparison will skew the conclusion towards similarity. You absolutely want to assure that you are capturing mainly the "steep" part of the curves. The sexy stuff in dissolution happens right where you are neither very early nor very late.

A comparison of plateau levels say nothing about product performance but just about relative maximum dissolution.

I could be wrong, but...

Best regards,
ElMaestro

No, of course you do not need to audit your CRO if it was inspected in 1968 by the agency of Crabongostan.

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