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New appendix added to Bioequivalence Trial Information (BTIF)

An appendix has been added to the Bioequivalence Trial Information Form (BTIF). Appendix 1 of the BTIF is an electronic copy of the AUC and Cmax data for the study summarized in the BTIF in MS Excel format.

A Completed Appendix 1 should be submitted with every BTIF for all future submissions.