IVIVC: Connecting the dissolution data to In vivo data

Definitions of in vitro-in vivo correlations is defined by FDA as “a predictive mathematical model describing the relationship between an in vitro property of an extended release dosage form and a relevant in vivo response.”

The FDA, EMA and USP define various levels of correlation from A to C. The classification is based on the ability of the correlation to reflect the complete plasma level profile from an in vitro parameter.

IVIVC and mainly level A IVIVC can be used in numerous cases. It is a powerful tool for development; it guarantees vivo performances as well as a gain of time. It can be used as a process control and quality control tool for the validation of the manufacturing control limits (dissolution limits). It facilitates certain regulatory determinations like minor variations and can be used as a surrogate of certain bioequivalence studies for extended release formulations (bio waiver) for example in the case of small modifications in the quantitative composition of the release excipients, dose strength, and small modifications of the manufacturing process or production site.

However in some cases IVIVC is not so easy to be established. That could be, for example, the case of long acting drugs as often dissolution is faster than in vivo release and then a time scaling approach is necessary. In other cases approaches must be different as for example for inhaled products which exhibit very fast absorption. Prodrugs are also another case as the drug followed in vivo is different from the API in the formulation.

The Advanced IVIVC Professional course will explain the concepts of IVIVC and mainly focus on the various problems accounted when establishing IVIVC .  Training will take place on 6 – 7 May 2019 in Athens, Greece. You can see the detailed event program at https://fleming.events/advanced-ivivc-professional-pharma-training/