Bioequivalence and Bioavailability Forum

Dear All,

In our BE study, We observed C_max at 0.25 hours (15 minutes) which is our first post dose time point.

Do we need to exclude those subjects with C_max at 15 min for statistical analysis?

USFDA guidance says "In the BE study, collection of blood samples at an early time point, between 5 and 15 minutes after dosing, followed by additional sample collections (e.g., two to five) in the first hour after dosing is usually sufficient to assess peak drug concentrations. Failure to include early (5- to 15-minute) sampling times leading to first time point C_max values may result in FDA excluding the data from affected subjects from the BE analysis."

To avoid exclusion of subject for statistical analysis, do we need to keep first point "at 15 minutes" or "between 5 and 15 minutes eg. 10 minutes"? Kindly clarify.

Is it applicable for modified Release product also?

Thanks and Regards
NK

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Edit: Category changed; see also this post #1. Guidance linked. [Helmut]