In response to pressure from healthcare providers to increase access to medicines while managing their costs, global regulators have been considering the requirements for encouraging increased generic competition. Specific attention has been given to the challenge of complex drug products where, due to the nature of the formulation or route of delivery, the development of generics is more difficult. In response, regulators such as the US FDA have released product-specific guidance documents aimed at advising generics manufacturers on the methods which should be applied to establish bioequivalence.

This webinar will address 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 Dr. Julie D. Suman, R.Ph., Ph.D., (Founder of Next Breath, an Aptar Pharma business), will examine the analytical methods and regulatory frameworks associated with ensuring and establishing bioequivalence.

The presenters will discuss 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 the utilization of component-specific morphological methods will be highlighted as a means to advance OINDP development.

  • 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

Series 1 – Focus on Pharma – Particle Sizing

Series 2 – Focus on Pharma – Elemental Analysis

Series 3 – Focus on Pharma – Solid Form Analysis

Series 4 – Focus on Pharma – Bioequivalence

Series 5 – Focus on Pharma – Enzyme Assays