Food effect [Regulatives / Guidelines]

posted by Compliance – India, 2013-08-26 14:04 (3983 d 14:50 ago) – Posting: # 11345
Views: 14,047

Dear All,

I was reviewing this revised guidance of EU for modified release formulation and i have one problem of understanding in the process mentioned in line 362, 363 and 364 about conduction of food effect study with compare to line 365, 366 & 367.

As per line 362 to 364, Food effect study is only require to conduct if the effect of the same is observed on Immediate formulation. I interpret it as only fasting is enough if the effect of food is absence or only fed is requires to be perform.

But as per the line 365 to 367, fast and fed both are suggested to be performed by default. Is it mean that fast and fed is necessary to perform in all cases however only fed is requires if effect of food is known as per IR formulation.

Please clear me on this to get the correct understanding about when to perform fasting and when to conduct fasting and fed both.

Thank you.



Edit: Subject line changed and moved to the suitable thread. [Helmut]

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