tlag‽ [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2017-08-03 19:47 (2506 d 21:15 ago) – Posting: # 17660
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Dear all,

In the product-specific guidance for Dimethyl fumarate gastro-resistant capsules 120 mg and 240 mg we find:

Main pharmacokinetic variables:
Single dose: AUC0-t, AUCinf, Cmax (tlag and tmax)
90% confidence interval: 80.00–125.00% for AUC0-t, AUCinf, Cmax. Comparable median and range for tlag and tmax.

I beg your pardon, tlag
For delayed release products any change in tlag directly translates into a shifted tmax (see this presentation, slides 53–58). Whilst the latter PK metric is generally already covered by rich sampling (in order to “catch” Cmax) this is not the case for tlag. I don’t get it.

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