Related Experiment Video
Updated: May 1, 2026

An In Vitro Dissolution Determination of Multi-Index Components in Tibetan Medicine Rhodiola Granules
Published on: November 4, 2022
In vitro- in vivo correlation's dissolution limits setting
B Roudier1, B M Davit, E Beyssac
1ESIEE Cités Descartes, BP 99, 93162, Noisy Le Grand Cedex, France, roudierb@esiee.fr.
Purpose:
In vitro in vivo correlation (IVIVC) is a biopharmaceutical tool recommended for use in formulation development. When validated, IVIVC can be used to set dissolution limits and, based on the dissolution limits, as a surrogate for an in vivo study. The purpose of this paper is to study the various methods used to fix dissolution limits.
Methods:
Fixing dissolution limits is not a straightforward process; various approaches exist. The classical ±10% of dissolution limits was compared to the recommended ±10% of Cmax and AUC and to an innovative back calculation of the 90% CI. Based on simulated values the influence of the calculation method as well as of the variability of the results and pharmacokinetic processes was investigated.
Results:
Depending upon the method, the results are different and their comparison leads to possible rules. It appears that the usage of a back calculation of a 90% CI is an accurate and advantageous method when intra-individual variability associated with the drug is low. Those findings are in accordance with the current practice of IVIVC, which is not recommended for highly variable drugs.
Conclusions:
The approach of using a 90% CI allows the intra-subject variability to be taken into account and fixes limits that ensure a greater chance to show acceptable BE, in case of reasonable intra-subject variability, leading to setting broader in vitro dissolution limits compared to classical solutions.
More Related Videos
08:46Implementation of In Vitro Drug Resistance Assays: Maximizing the Potential for Uncovering Clinically Relevant Resistance Mechanisms
Published on: December 9, 2015
08:54Broth Microdilution In Vitro Screening: An Easy and Fast Method to Detect New Antifungal Compounds
Published on: February 14, 2018
Related Concept Videos
Drug Product Performance: In Vitro–In Vivo Correlation
Theories of Dissolution: Diffusion Layer Model
This process starts with a thin layer, saturated with the drug, forming at the interface between the solid and liquid. The solute then diffuses from this layer into the main solution. The Noyes-Whitney equation suggests that the rate of dissolution relies on the diffusion...
Clinically Relevant Drug Product Specifications: Methods of Establishment
In Vitro Drug Dissolution: Compendial Testing Models II
In Vitro Drug Dissolution: Compendial Testing Models I
In Vitro Drug Release Testing: Overview, Development and Validation