Food effect [Regulatives / Guidelines]

posted by Dr_Dan  – Germany, 2013-08-26 18:48 (3679 d 08:27 ago) – Posting: # 11351
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Dear Compliance
This was a topic at the EUFEPS meeting in Bonn followed by an intensive discussion. Andrzej Dzierbicki from Polpharma pointed out that a food effect study of the new MR formulation should be considered sufficient as food effect related to drug substance/IR formulation is known. Such food effect study results of the new MR formulation can be compared with historical/published data of food effect of an IR formulation irrespective of whether clinically significant food effect was observed for the IR formulation or not. Studies are sufficiently standardized to allow for rough estimation of effect size. However, it is not clear how the PK working group will react on this objection. We need to see the final version of the guideline.
Kind regards

Kind regards and have a nice day

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