Related Experiment Video
Updated: Apr 7, 2026

Implementation of In Vitro Drug Resistance Assays: Maximizing the Potential for Uncovering Clinically Relevant Resistance Mechanisms
Published on: December 9, 2015
In vitro-in vivo correlations: general concepts, methodologies and regulatory applications
Ignacio González-García1,2, Victor Mangas-Sanjuán1,2, Matilde Merino-Sanjuán2,3
1a Department of Engineering , Area of Pharmaceutics and Pharmaceutical Technology, Miguel Hernández University , Elche , Spain .
Abstract:
The major objective of in vitro-in vivo correlations is to be able to use in vitro data to predict in vivo performance serving as a surrogate for an in vivo bioavailability test and to support biowaivers. Therefore, the aims of this review are: (i) to clarify the factors involved during bio-predictive dissolution method development; and (ii) the elements that may affect the mathematical analysis in order to exploit all information available. This article covers the basic aspects of dissolution media and apparatus used in the development of in vivo predictive dissolution methods, including the latest proposals in this field as well as the summary of the mathematical methods for establishing the in vitro-in vivo relationship and their scope and limitations. The incorporation of physiological relevant factors in the in vitro dissolution method is essential to get accurate in vivo predictions. Standard quality control dissolution methods do not necessarily reflect the in vivo behavior, so they rarely are useful for predicting in vivo performance. The combination of physiological based dissolution methods with physiological-based pharmacokinetics models incorporating gastrointestinal variables will lead to robust tools for drug and formulation development, nevertheless their regulatory use for biowaiver application still require harmonization of the mathematical methods proposed and more detailed recommendations about the procedures for setting up dissolution specifications.
Related Concept Videos
Drug Product Performance: In Vitro–In Vivo Correlation
Equivalence: In Vitro and In Vivo Bioequivalence
In Vitro Drug Release Testing: Overview, Development and Validation
Methods for Studying Drug Absorption: In vitro
The diffusion cell method uses a two-compartment cell, including a donor compartment with the drug solution, which simulates the environment where the drug is applied, and a receptor compartment with a buffer solution, which simulates the environment...
Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions
Clinically Relevant Drug Product Specifications: Methods of Establishment

