This webinar addressed key questions such as, what are the novel analytical methods relevant to OINDP in vitro bioequivalence studies? Also, what supporting evidence can be generated to aid formulation optimization and therefore help speed successful product development and regulatory submission?
This webinar, led by OINDP experts from Aptar Pharma companies Next Breath and Nanopharm, examined the analytical methods and regulatory frameworks associated with ensuring and establishing bioequivalence.
The presenters discussed the multiple, sometimes interconnected, strategies for reducing cycle times for OINDP development projects and how such strategies can be implemented in a practical way. In addition, technologies such as utilization of component-specific morphological methods will be highlighted as a means to advance OINDP development.
발표자Dr. Jag Shur CEO, Nanopharm & Dr. Julie D. Suman, R.Ph., Ph.D., Founder & President, Next Breath
- What will you learn?
- Learn how to optimize your analytical strategy to speed formulation development and regulatory submission
- Discover a combination of analytical techniques which support in vitro establishment of bioequivalence
- Understand more about the particular challenges of developing and manufacturing OINDPs
- Learn more about the regulatory guidance for the development of complex generic drug products