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

posted by MSimoes – Portugal, 2019-07-17 18:13  – Posting: # 20383
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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,
Marta

Regards,
MSimoes

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