Statistical comparison of dissolution profiles - variable nr of units [Dissolution / BCS / IVIVC]

posted by MSimoes – Portugal, 2019-07-17 16:13 (385 d 03:08 ago) – Posting: # 20383
Views: 1,582

Dear BEBAC team,

What is your position on comparing dissolution profiles with different number of units? As far as I know, guidelines state one should use 12 units of each batch. However, sometimes and for QC reasons, we have 18 units of one batch and 12 units of another.

I don't think we should "choose" ou "not consider" some of the results, but then we are in a grey zone in the regulatory area. Is this comparison (18 vs 12 units, or other!) acceptable for f2, bootstrap f2 and MSD? What is your experience?

Thanks in advance,


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