Include: Biopharmaceutic studies in Module 5.3.1 of the CTD.
When submitting biopharmaceutic data:
The optional Bioequivalence Study Information Form may replace the requirement to complete the Summary of a Bioavailability or Bioequivalence Study form and some other requirements.
Provide electronic and paper copies of the individual subject concentration versus time results, and the individual subject pharmacokinetic parameters from the pivotal biopharmaceutic studies.
Include the study report and confirmation that all biopharmaceutic studies submitted to the TGA have been:
carried out in accordance with the Declaration of Helsinki, and the principles of good clinical practice
approved by an appropriate independent ethics committee or institutional review board.
Identify and provide reasons, in Clinical Overview in Module 2 and Module 5.3.1 of the CTD, for any studies that have not been conducted in accordance with these requirements.
