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I'm looking for some clarification on the EMEA guidance on
bioequivalence testing for modified release forms (CPMP/EWP/280/96 pg
11). We're working on a generic modified release formulation, where
the data from the literature clearly indicates no food effect for the
According to this guidance we need only perform a single dose, two way,
high fat, crossover study. I have three questions about this:
1) What is the scientific basis for the decision to eliminate a two way
fasting crossover study?
2) Are the discussions that led to this guidance archived, either on
the web or in a library? For example the current version is listed as
Draft 15, where is Draft 1-14 located?
3) In what countries is this guidance accepted as the rule for studies.
CTS Chemical Industries
Kiryat Maalchi, Israel
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