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Registertlag‽ [Regulatives / Guidelines]
posted by Helmut 
– Vienna, Austria, 2017-08-03 19:47 (3247 d 16:36 ago) – Posting: # 17660
Views: 10,445
Dear all,
In the product-specific guidance for Dimethyl fumarate gastro-resistant capsules 120 mg and 240 mg we find:
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.
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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Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- EMA Product Specific GL mmw 2017-07-14 14:50
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Ing. Helmut Schütz