Forced Degradation for Pharmaceuticals 2015

Topics

• Sharing experiences of successful stress testing conditions and limits
• Comparing and practically complying with regulatory requirements for forced degradation studies in Europe, USA and Japan
• Best practices for conducting photolytic degradation studies
• Practically carrying out oxidative degradation studies
• Generics perspective: Practically designing and implementing forced degradation studies
• Accurately predicting drug product and drug substance shelf-life through science-based accelerated degradation studies
• Practically applying genotoxic impurity guidelines to forced degradation studies, including ICH M7
• Forced degradation and stability studies – from small to large - similarities and differences
• Successfully implementing excipient compatibility studies and understanding the impacts of excipients on degradation pathways to optimise formulation development
• Practically implementing forced degradation studies for drug product development
• Practically applying QbD to forced degradation studies

Who should Attend

Attendees involved in:

• Development
• Analytical
• Formulation
• Stability
• Chemistry
• R&D