The Importance of Stability Studies in US Drug Development

Stability studies are frequently the rate limiting activities for submitting new drug applications (NDAs) for new drug products (including combination products). The principal goals of such studies are to establish the storage conditions and shelf life of the product and should be considered in your project timeline to avoid delaying your marketing application submission.

Download this article to learn more about:

  • The impact of stability studies on product quality and safe clinical and commercial use
  • When stability studies should be initiated during the development lifecycle
  • ICH guidances applicable to stability studies
  • Understanding degradation pathways