In Vitro-In Vivo Correlation (IVIVC) and Determining Drug Concentrations in Blood from Dissolution Testing – A Simple and Practical Approach

ABSTRACT

Evaluating an IVIVC is a desirable feature for any drug dissolution test to establish relevance and confidence in assessing the quality and safety of solid oral dosage products, such as tablets and capsules. However, success in this area has been limited. One of the reasons for this lack of success may be that the approaches described in the literature to achieve IVIVC appear to be intuitive expectations rather than an objective end-point based on scientific rationale. For example, rather than predicting an in vivo response based on in vitro results, which is the objective of IVIVC, attempts are usually made to match in vitro results with in vivo results by adjusting experimental conditions for in vitro testing. This article provides a discussion and clarification on the underlying scientific principles to help in alleviating current difficulties in developing IVIVC. Further, it provides a simpler and practical approach based on experimental studies to achieve appropriate IVIVC by predicting blood drug levels from dissolution results.

Keywords:

Drug dissolution, IVIVC, convolution method, product independent procedures, method development, comparative release characterisation.