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

posted by ElMaestro  – Belgium?, 2019-07-17 19:02 (499 d 10:56 ago) – Posting: # 20384
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Hi MSimoes,

» 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?

That should generally be ok, in my experience.

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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