BA/BE & Biowaivers

BA/BE & Biowaivers is a course dedicated to BABE design including all practical aspects related.

Topics

• BABE design
• Bioavailability and Bioequivalence
• Computation of PK parameters-statistical analysis
• Practical aspects
• Biowaiver principles
• Specific cases & legal aspects
• Regulatory & legal aspects of biowaivers
• The use of different types of biowaivers
• Dissolution Setting specifications
• Development of dissolution tests as support of BE and biowaivers

Who should Attend

• Regulatory affairs professionals
• BA/BE managers
• Dissolution testing specialists
• Pharmacokineticists
• Formulation managers
• IVIVC specialists
• Project Development Manager
• Formulators