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.
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.