Bioequivalence and Bioavailability Forum

My pilot bio study passed which was single dose,single treatment cross -over study with 90% CI 87 - 118% on 16 subjects but pivotal bio study of same fails i.e 82 - 147 %, the dissolution profiles, physicochemical properties were also same,there is no any significant difference between both batches, analytical method validation was also up to the mark, then please tell me what are the potential factors for passing and failure of same formulation.

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Edit: Please follow the Forum’s Policy. Category changed (see this post #1). Please give complete information about the pivotal study; see also this post #4. [Helmut]