What are ADME and IVIVC in drug development?

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Jan 5, 2024
min read
What are ADME and IVIVC in drug development?

ADME is an acronym that stands for Absorption, Distribution, Metabolism, and Excretion. In the context of drug development, ADME refers to the study of how a drug is absorbed into the body, distributed throughout different organs and tissues, metabolized by enzymes, and eliminated from the body.

Absorption: Involves the movement of a drug from the site of administration (e.g., oral, intravenous, dermal) into the systemic circulation. Factors such as drug formulation, bioavailability, and permeability influence drug absorption.

Distribution: Once in the bloodstream, the drug is transported to various organs and tissues through the circulatory system. The extent of distribution is influenced by factors like blood flow, drug-protein binding, and tissue permeability.

Metabolism: Metabolism refers to the chemical transformation of a drug by enzymes in the body, particularly in the liver. This process converts the drug into metabolites, which can be more active, less active, or inactive compared to the parent drug. Metabolism plays a crucial role in determining the duration and intensity of a drug's effect.

Excretion: Excretion involves the removal of a drug and its metabolites from the body. The primary route of drug excretion is through the kidneys via urine. Other routes include bile excretion into the intestines, breath, and sweat.

Studying ADME properties is important in drug development as it helps in understanding and predicting the pharmacokinetics and pharmacodynamics of a drug. By evaluating these factors early in the drug discovery process, researchers can assess the drug's efficacy, safety, and potential for drug-drug interactions.

IVIVC stands for In Vitro-In Vivo Correlation. It is a methodology used in pharmaceutical drug development to establish a relationship between the in vitro release of a drug from a dosage form and its in vivo performance in the body. IVIVC involves developing a predictive model that relates the dissolution or release rate of a drug from a dosage form to its pharmacokinetics (absorption, distribution, metabolism, and excretion) in the body.

By establishing an IVIVC, pharmaceutical companies can use in vitro dissolution data obtained during formulation development to predict the in vivo drug behavior, such as the rate and extent of drug absorption. This correlation allows for the optimization and predictability of drug delivery systems, including controlled-release formulations, to ensure that the desired therapeutic levels of the drug are achieved in the body.

Overall, IVIVC is an important tool in drug development as it helps streamline the formulation development process, optimize dosage forms, and ensure the safety and efficacy of pharmaceutical products in patients.

What is the meaning of IVIVC?

Pion Inc. has been helping drug formulators in their drug development efforts for more than 20 years. With tools to help assess dissolution and permeability, Pion focuses on the "A" in ADME and helps establish a correlation between in vitro results and in vivo outcomes. Contact us to learn more.

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