Stability Studies

Regulators require stability studies to show that your drug product is safe and effective during its shelf life.  While accelerated stability studies are useful for predicting potential degradation products and appropriate analytical methods, they are not sufficient for regulatory approval.  IBI has wide ranging experience of performing both accelerated and real-time stability studies. 

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Below is a list of just some of the types of GMP and nonGMP capabilities of Integrity Bio:

  • Expiry
  • Batch to batch comparability
  • The selection of alternative excipient vendors
  • Manufacturing condition changes
  • Performance of delivery devices
  • Preparation of backup formulations
  • Clinical needs and requirements
  • Drug interactions
  • Container closure systems
  • Excursions from recommended handling conditions