Revised Appendix for Bioequivalence Trial Information (BTIF)

In September 2018, an appendix was added to the Bioequivalence Trial Information Form (BTIF), which consisted of an electronic copy of the AUC and Cmax data for the study summarized in the BTIF in MS Excel format.

A newly revised version of the appendix is now available on the website and this version should be used for all future applications. The appendix has been revised to include a sheet for the individual subject concentration-time data in addition to the AUC and Cmax data already requested.