News
27 January, 2017 - 01:00 (CET)
Alerts
M
The revisions to the BTIF (Bioequivalence Trial Information Form) include the following changes to facilitate study assessment:
- a reorganization of some sections,
- addition of some information fields to the bioanalysis sections, and
- a clarification of the wording of some fields.
The revisions are designed to provide a more complete and better organized summary of a bioequivalence study being submitted to PQTm as part of a product dossier.
The new BTIF will be required in dossiers submitted after 1 March 2017.