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RegisterScience first! [Regulatives / Guidelines]
posted by Helmut 
– Vienna, Austria, 2013-12-23 16:41 (4565 d 10:39 ago) – Posting: # 12099
Views: 3,352
Hi Jay,
I expect only a general statement in the MR GL. Maybe we will see particular truncation time-points in the product-specific guidances. However, never follow GLs unreflected.
❝ Hope the Guideline gets published soon and provides clarity for truncation point of pAUC.
I expect only a general statement in the MR GL. Maybe we will see particular truncation time-points in the product-specific guidances. However, never follow GLs unreflected.
Science should always be the basis
of regulatory requirements. Joachim Röhmel
Recipe for success:
Treat guidelines like variable constants. ElMaestro
Guidelines
are guidelines
are guidelines. Henrike Potthast
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Helmut Schütz
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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 MR Draft Guidelines Application Jay 2013-09-16 15:39
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- EMA MR Draft Guidelines Application jag009 2013-09-16 17:30
- EMA MR Draft Guidelines Application Helmut 2013-09-17 13:35
- EMA MR Draft Guidelines Application Jay 2013-12-23 11:00
- EMA MR Draft Guidelines Application Helmut 2013-12-23 13:54
- EMA MR Draft Guidelines Application Jay 2013-12-23 14:54
- Science first!Helmut 2013-12-23 15:41
- EMA MR Draft Guidelines Application Jay 2013-12-23 14:54
- EMA MR Draft Guidelines Application Helmut 2013-12-23 13:54
- EMA MR Draft Guidelines Application Jay 2013-12-23 11:00
Ing. Helmut Schütz