Stability Testing in Pharmaceutical Development

DAY 1

Introductions

• The life cycle approach to product development and Quality by Design
• Stability testing in product development 

Lunch

• ICH Guidance Q1A (R2) – a comprehensive review 
• Case study
  "Effect of Processing and Formulation Variables on the stability of a salt of a weakly basic drug candidate (tablet)" – Badawy et al, BMS 
• EU GMP guidance on stability testing

DAY 2

• ICH Q6 – specifications, and how to set them.   Role of specifications in stability testing.   Alternative approaches to deriving specifications
• Evaluation of stability data – ICH guidance Q1E.   Identifying out of trend data.   Alternative approaches. 
• Data interpretation case studies including attendee problems

Lunch

• Bracketing and matrixing designs for stability testing of new drug substances and products - ISC Q1E 
• Photostability testing—Q1B 
• Action Planning and Final Q&A

Workshop and examples based on delegate’s interests
Group discussion, problem solving and consultancy