Use in development, submission and post approval changes
All sessions of this unique course online
Live interaction options between the delegates and trainer
Available via mobile, tablet or laptop
This practical course provides an in-depth understanding of BABE design including all practical aspects related to bioavailability & bioequivalence.
The series of case studies & discussions will bring clarifications on the computation of PK parameters, use of different types of biowaivers & related regulatory and legal aspects. You will learn about the development of dissolution tests as well as how to achieve QA/QC compliance.
Reveal the full schedule of the training as well as key topics, course objectives, key takeaways, special features, and the trainer bio!
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
