ICH Stability Requirements: Overcoming the Challenges

Presentation by: Wayland Rushing, Ph.D, EAG Laboratories’ Director of Scientific Affairs

Compliance with ICH stability requirements are a necessary step in getting new drugs approved. Failure to comply with these requirements can lead to regulatory headaches and delays in your development programs. In this presentation, learn how to navigate the requirements of ICH – the International Conference of Harmonization of Technical Requirements for Registrations of Pharmaceuticals for Human Use: ICH Q1A, Q1B, Q1C, Q1D, and Q1E, and Q5C.

These guidelines aim to increase international harmonization of the requirements, reduce duplicating efforts and keep development costs down while the data required for determination of retest dates and establishing product shelf life.

In this presentation, you will learn about:

  • Requirements for ICH stability studies for API’s and DP’s
  • How to design the appropriate stability study for your product
  • How to interpret the data generated during the stability study

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