Canada-Comparative bioavaiability standards [BE/BA News]
Dear all,
Guidance Document of "Comparative Bioavailability Standards: Formulations Used for Systemic Effects" is updated and shall be effective from 01/07/2018 and applicable for submission after september 1 2018.
This guidance is now more descriptive in bioequivalce standards specially in critical and HVD proudcts.
Edit: Please don’t shout! Post moved to a related thread. [Helmut]
Guidance Document of "Comparative Bioavailability Standards: Formulations Used for Systemic Effects" is updated and shall be effective from 01/07/2018 and applicable for submission after september 1 2018.
This guidance is now more descriptive in bioequivalce standards specially in critical and HVD proudcts.
Edit: Please don’t shout! Post moved to a related thread. [Helmut]
Complete thread:
- Updated TPD BE guidances BRB 2018-06-18 22:53 [BE/BA News]
- Updated TPD BE guidances Helmut 2018-06-19 01:32
- Canada-Comparative bioavaiability standardsSandeep 2018-06-27 12:36