BA/BE & Biowaivers is a course dedicated to BABE design including all practical aspects related.
BA/BE & Biowaivers covers topics such as:
- 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
BA/BE & Biowaivers brings together:
- Regulatory affairs professionals
- BA/BE managers
- Dissolution testing specialists
- Pharmacokineticists
- Formulation managers
- IVIVC specialists
- Project Development Manager
- Formulators