tlag‽ [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2017-12-21 16:41 (2366 d 23:31 ago) – Posting: # 18077
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Hi nobody,

❝ ...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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