Registration Stability Case Study

Stability storage and testing

Join Dr. Mark Powell as he runs through a registration stability case study. Registration stability is a key component of a marketing authorisation application or new drug application. This webinar covers the general considerations for registration stability, including EMA and US FDA requirements, and presents a case study for a solid oral dosage form.

It also covers:

  • Overview of regulatory requirements
  • Attributes to measure and frequency
  • Managing stability chamber excursions and pull schedules
  • Case study: registration stability for a solid oral drug product