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

posted by Obinoscopy  – USA, 2018-09-12 00:38 (1013 d 21:44 ago) – Posting: # 19264
Views: 3,522

» Thanks but the person who told me insisted that it is the correct way :confused::confused::confused:

I just checked the WHO interchangeability guideline, it states:

"a maximum of one-time point should be considered after 85% dissolution of the reference (comparator) product has been reached; in the case where 85% dissolution cannot be reached...the dissolution should be conducted until an asymptote (plateau) has been reached"

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.

Regards,

Scopy

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