November 19, 10:00 am EST
In this webinar, Dr. Cardot will discuss two main aspects linked with inter subject variabilities: averaging of data and scaling between studies. When two steps IVIVC are set up, authorities propose to mean the absorption for establishing IVIVC. For averaging, the following points will be discussed:
- The influence of averaging mean curve of absorption profiles
- When averaging makes sense
- Use of mean, median, or geometric mean
- When can mean plasma curves be used.
The scaling between studies will be investigated in order to avoid misinterpretation during IVIVC when data from various studies are used. In this respect the following points will be presented:
(i) Scaling between studies using results from a common formulation
(ii) Use of common UIR for all subjects when individual UIR are not existing.
講師： Dr. J-M. Cardot, Pharm D, Ph.D. Professor and head of the Department of Biopharmaceutics and Pharmaceutical Technology at the Auvergne University.