In vitro in vivo correlation IVIVC

In Vitro-In Vivo Correlation (IVIVC) is a predictive mathematical model that describes the relationship between an in vitro property of a drug (such as the rate of drug release or dissolution) and an in vivo response (such as the rate and extent of drug absorption)

In Vitro Studies:

Conducted in a controlled laboratory environment outside of a living organism. For drugs, this often involves testing the dissolution of the drug in different media, simulating the conditions it would encounter in the gastrointestinal tract.

In Vivo Studies:

Performed within a living organism, such as in animal models or humans. Involves measuring the pharmacokinetics (how the drug is absorbed, distributed, metabolized, and excreted) after the drug is administered.

Purpose of IVIVC:

Predict Drug Performance: IVIVC is used to predict how a drug formulation will perform in vivo based on its in vitro characteristics. This can be particularly useful during drug development to optimize formulations and reduce the need for extensive human or animal testing.

Regulatory Approval: IVIVC can support regulatory filings by providing evidence that in vitro testing can reliably predict in vivo outcomes, which can streamline the approval process.

Batch Consistency: It helps in ensuring that different batches of the same drug product will perform consistently when administered to patients.

Types of IVIVC:

Level A Correlation:

Represents a point-to-point relationship between in vitro dissolution and in vivo drug absorption.

Most commonly accepted by regulatory agencies because it provides the highest level of confidence in predicting in vivo behavior.

Level B Correlation:

Based on statistical moment analysis. It relates the mean in vitro dissolution time to the mean in vivo residence time or mean absorption time. Less direct than Level A but still useful.

Level C Correlation:

Represents a single point relationship, such as the percentage of drug dissolved in vitro at a particular time to a pharmacokinetic parameter like C_max (maximum concentration) or AUC (area under the curve). Provides limited information but can be useful in certain cases.

Multiple Level C Correlation:

Involves more than one-time point in vitro dissolution parameter related to one or more in vivo parameters. Provides more detailed information than a simple Level C but is still less comprehensive than Level A.

Importance:

Cost and Time Efficiency: A well-established IVIVC can reduce the need for extensive in vivo testing, saving time and resources in drug development.

Regulatory Compliance: It supports the justification for changes in drug formulation or manufacturing processes without the need for additional clinical studies.