Students will be able to describe the difference between small molecule and protein drug stability testing.  In addition, students will be able to explain the  ICH-Q1 guidelines and how they are applied to drug development and approvals. This course would be most suitable for: drug developers, drug manufacturers, regulatory affairs, regulatory assessors, and site inspectors.

Course Outcomes

• Understand the expectations of stability studies and appreciate use of risk management
• Describe the stability testing of new drug substances and products as outlined in the ICH Q1A(R2) and define stability testing for new dosage forms in ICH-Q1C.
• Describe the WHO guidelines on stability testing of active pharmaceuticals in climatic zones III and IV, which replaced ICH-Q1F.
• Explain ICH Q5C guideline.
• Explain the importance of photostability testing of new drug substances and products in ICH-Q1B.
• Demonstrate the bracketing and matrixing ICH-Q1D
• Evaluation of stability data as explained in ICH-Q1E.

Successful learners can earn a Level 1 badge than can be showcased on their digital profile or resume.