BA/BE & Biowaivers

https://fleming.events/bioavailability-bioequivalence-and-biowaivers/

This practical course provides an in-depth understanding of  BABE design including all practical aspects related to bioavailability & bioequivalence.

Key topics:

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

Training audience:

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