In-Vitro In-Vivo Correlation (IVIVC) is described by the regulators as a predictive mathematical tool to describe the relationship between an In-Vitro dosage form and an In-Vivo response. It is a critical model described in many guidelines and its usage in development is recommended to reduce the risk of in-vivo testing (human studies).
This 2-day practical training course will provide you with an interactive environment to learn best practice for running IVIVC studies. You will examine the data needed to establish IVIVC and discuss the regulatory framework for IVIVC in the US (FDA), EU (EMA), Japan (Pmda) and others. Crucially you will address the many implementation issues experienced by professionals and solutions to overcome them. The course is full of exercises and case studies to meet your goals and tackle your everyday challenges.
J-M. Cardot is professor and Head of the Department of Biopharmaceutics and Pharmaceutical Technology at the Universite d’Auvergne, France. The research fields of his laboratory are dissolution, bioequivalence and IVIVC. His personal research fields are biopharmaceutical development of drugs, in vivo bioequivalence and in-vitro in-vivo correlation
This course is aimed at professionals with experience knowledge in drug development areas such as formulation, quality and dissolution testing and who want to learn more about the techniques and calculations involved in In Vitro In Vivo correlation. It will be beneficial to personnel working with generics and in the following areas:
This course is approved by the Royal Society of Chemistry for the purpose of continuing professional development.
As the UK’s professional body for chemical scientists, the Royal Society of Chemistry supports professional development by listing excellent training opportunities on their database of approved courses. The approval process is one of peer review, involving assessment against set criteria by members that are expert in their field.
Very good and interesting course. A lot of hands on training!