Related Experiment Video
Updated: May 5, 2026
06:23
Applying Advanced In Vitro Culturing Technology to Study the Human Gut Microbiota
Published on: February 15, 2019
13.1K
In Vitro-in Vivo Correlation: An Unrealistic Problem
1Bereich Forschung und Entwicklung des VEB Jenapharm, DDR-6900, Jena.
Pharmaceutical Research
|November 26, 2013
Summary
True in vivo-in vitro correlation is impossible. Attempts to link in vitro data with human biopharmaceutical or pharmacokinetic data are scientifically unachievable, presenting a chimerical challenge in drug development.
Area of Science:
- Pharmacokinetics and Biopharmaceutics
- Drug Development Science
Background:
- In vitro dissolution testing is widely used to predict drug absorption.
- Establishing a reliable in vivo-in vitro correlation (IVIVC) is crucial for drug product development and regulatory submissions.
Purpose of the Study:
- To critically evaluate the feasibility of establishing a true in vivo-in vitro correlation.
- To analyze the scientific basis for correlating in vitro data with in vivo human pharmacokinetic and biopharmaceutical parameters.
Main Methods:
- Comprehensive literature review of existing studies on IVIVC.
- Analysis of theoretical and practical limitations in correlating in vitro and in vivo data.
- Evaluation of biopharmaceutical and pharmacokinetic principles.
Main Results:
- The review concludes that a true in vivo-in vitro correlation cannot be established.
- Existing data suggests that attempts to quantitatively or qualitatively correlate in vitro results with human biopharmaceutical or pharmacokinetic data are fundamentally flawed.
- Significant variability and confounding factors prevent reliable prediction.
Conclusions:
- The concept of a true in vivo-in vitro correlation is scientifically untenable.
- Reliance on IVIVC for regulatory decision-making or prediction of human drug behavior is ill-advised.
- Alternative approaches may be needed to assess drug product performance and bioavailability.
Related Concept Videos
01:20Drug Product Performance: In Vitro–In Vivo Correlation
439
In pharmaceutical development, it's crucial to establish a predictive in vitro–in vivo correlation (IVIVC) for two or more formulations to gain a comprehensive understanding of release properties. IVIVC reduces the need for costly in vivo studies and facilitates the establishment of meaningful dissolution specifications with significant cost savings and decreased regulatory burden. Furthermore, a meaningful IVIVC should predict Cmax and AUC within 20%, aligning with FDA guidance while...
439
01:17Equivalence: In Vitro and In Vivo Bioequivalence
390
Bioequivalence studies are crucial in evaluating whether new drugs can match an approved one regarding pharmacological effects and clinical performance. These studies test if drugs, despite different dosage forms, share identical plasma concentration-time profiles. Three types of equivalence are central to these studies: chemical, pharmaceutical, and therapeutic. Chemical equivalence indicates that two or more drug products contain identical active ingredients in equal amounts. Pharmaceutical...
390
01:24Pharmacokinetic–Pharmacodynamic Relationship: Problems
129
The empirical approach to drug therapy optimization relies on correlating pharmacological response with administered dosage. Such an approach can be costly, time-consuming, and often yields poor correlation due to variables like formulation factors and drug elimination characteristics. A more precise approach correlates response with plasma drug concentration or the amount of drug in the body, rather than dosage. This is achieved through pharmacokinetic-pharmacodynamic (PK/PD) modeling, which...
129
01:16Methods for Studying Drug Absorption: In vitro
845
In vitro experiments are crucial for understanding the transport and absorption of drugs through biological materials. These studies employ varied methods such as the diffusion cell method, the everted sac technique, and the everted ring technique.
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...
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...
845
01:16In vitro Mutagenesis
4.9K
4.9K
01:16In-vitro Mutagenesis
14.8K
To learn more about the function of a gene, researchers can observe what happens when the gene is inactivated or “knocked out,” by creating genetically engineered knockout animals. Knockout mice have been particularly useful as models for human diseases such as cancer, Parkinson’s disease, and diabetes.
14.8K