Monthly Archives: December 2010

Level A IVIVC – Impractical and unreasonable expectations

An IVIVC (in vitro-in vivo co-relationship) is a terminology commonly used in the area of drug dissolution testing desiring relationship of in vitro (drug dissolution) results with in vivo characteristics such as drug levels in humans.

As the in vitro results are generally expressed as cumulated percent drug release, thus these profiles (results) are difficult to compare with in vivo results which are reported in concentration units. In addition, in vitro results only reflect release (dissolution) characteristics of a product while in vivo results reflect combined effect of drug dissolution and absorption/elimination characteristics. To achieve appropriate comparison, either the in vitro dissolution results are manipulated (mathematically) using drug absorption/elimination characteristics to predict blood levels and compared with actual/observed drugs levels or by extracting in vivo dissolution results from actual drug levels in humans and to compare with the observed in vitro results. The first approach is known as a convolution technique and the second as de-convolution. One of these techniques of data manipulation would be required to make the results comparable. Continue reading