Yvonne
☆    

2012-01-04 13:55
(5290 d 21:29 ago)

Posting: # 7862
Views: 1,535
 

 solid dispersion reference not test fed and fasting study? [Regulatives / Guidelines]

Could anybody help me with the following question:

We would like to conduct BE studies for the European market, for a test product which will be a wet granulation formulation. The reference product is a solid dispersion formulation.
The product has to be taken with or without food (there is a food effect).

In the EMA guideline on the investigation of bioequivalence it is stated:

"However, for products with specific formulation characteristics (e.g. microemulsions, solid dispersions), bioequivalence studies performed under both fasted and fed conditions are required unless the product must be taken only in the fasted state or only in the fed state."

Since the test product has no specific formulation charateristics do we have to perform a study in the fasted state or in the fasted and fed state?
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