After having read the FDA's guidance for seeking BE on Ecosapent Ethyl, I feel that Amarin should petition the FDA to tighten up the wording in the In Vivo section, specifically the language: "should consist of a high-fat, high-calorie, EPA limited meal".
The term "EPA limited meal" is rather ambiguous at best and does not set any parameters or threshold for the amount of EPA that might be introduced via the test subjects meals, thus leaving a huge loophole for submissions to skew the apparent outcome of results and more easily attempt to show that their entry has the bio equivalence to V.
IMO, the wording should set a quantifiable threshold on the allowable amount of dietarily introduced EPA on a Mg per Kg of test subject body weight as opposed to simply saying:"EPA limited meal".
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