ABSTRACT
Sponsors would do well if they require their contract research organizations (CROs) to produce these reports in a clear, comprehensive format that allows easy access to all the information submitted. Whereas the Food and Drug Administration (FDA) does not require any specic format for the submission of the report, the layout described here has been successful in achieving fast approval of bioequivalence (BE) studies and it is recommended that sponsors check their CRO’s standard format against the recommendations made here for the purpose of assuring completeness, accuracy, ready accessibility, and compliance (Tables 18.1 and 18.2).
