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Back to the forum  Query: 2017-10-19 00:17 CEST (UTC+2h)
 
mmw
Junior

India,
2017-07-14 14:50

Posting: # 17548
Views: 884
 

 EMA Product Specific GL [Regulatives / Guidelines]

Dear all,

EMA adopted a new batch of product specific guidances. Published on 10/07/2017:

Crizotinib
Elvitegravir / cobicistat / emtricitabine / te­no­fovir disoproxil
Elvitegravir
Emtricitabine, rilpivirine, tenofovir, disopro­xil
Vortioxetine

Thanks

MMW
Helmut
Hero
Homepage
Vienna, Austria,
2017-07-28 12:40

@ mmw
Posting: # 17620
Views: 574
 

 EMA Product Specific GL


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Helmut Schütz 
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The quality of responses received is directly proportional to the quality of the question asked. ☼
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Helmut
Hero
Homepage
Vienna, Austria,
2017-08-03 17:47

@ Helmut
Posting: # 17660
Views: 488
 

 tlag‽

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.

[image]All the best,
Helmut Schütz 
[image]

The quality of responses received is directly proportional to the quality of the question asked. ☼
Science Quotes
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