Considerations with the Development of Inhaled Combination Products

3/17/2021 14:45 - 15:20

The development of any pharmaceutical product is a challenge, but the development and regulatory hurdles are even greater for an inhaled product.

Furthermore, most inhaled products are also combination products and that adds another layer of complexity, both from a technical, and a regulatory perspective, and thus there is increased risk of failure. This presentation will address the following:

  • What are the regulatory considerations for inhaled combination products?
  • What analytical tests are required for QC release and stability testing of inhaled combination products?
  • When can characterization studies be conducted during development to replace routine QC testing?

David Cipolla, Vice President of Research, Insmed Inc.