Variability (MR vs. IR) [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2013-09-12 17:23 (3662 d 09:00 ago) – Posting: # 11485
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Dear all,

one goody slipped trough my attention, namely lines 340–344:

The inter-individual variability of the pharmacokinetic parameters of interest should be deter­mined in the single dose or multiple dose studies […] and should be compared between the modified and immediate release formulation. The variability of the modified release formulation should preferably not exceed that of the immediate release formulation.

OK, but how to do that? I guess one-sided (non-superiority) of inter-subject variance is meant. But the inter-subject variance is only accessible in a crossover or a paired design: If we have a SD and a MD study we can only assess the total (pooled) variance.

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