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Registertlag‽ [Regulatives / Guidelines]
posted by Helmut 
– Vienna, Austria, 2017-12-21 16:41 (3113 d 14:20 ago) – Posting: # 18077
Views: 9,505
Hi nobody,
Splendid idea! Why not an early partial AUC?
Yep.
Strange. The MR-GL suggests for delayed release multiple unit formulations (if SmPC recommends intake under fed conditions): SD fasting and fed.
Do you mean why no MD study? That’s consistent with the MR-GL.
❝ ...somebody had a look at the ADRs (mostly upper GI-tract-related, therefore the gastroresistant formulation) and said, hey, we have to "quantitate" the quality of the gastroresistant part of the formulations. Let's do tlag!
Splendid idea! Why not an early partial AUC?
❝ afaik the SmPC recommends application in fed state, due to better tolerability.
Yep.
❝ The EMA guideline gives no recommendation re. fasted/fed?!
Strange. The MR-GL suggests for delayed release multiple unit formulations (if SmPC recommends intake under fed conditions): SD fasting and fed.
❝ On the other hand: Modified release with one single-dose study only?
Do you mean why no MD study? That’s consistent with the MR-GL.
—
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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 Product Specific GL mmw 2017-07-14 14:50
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Ing. Helmut Schütz