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In Vitro – In Vivo correlation

In Vitro – In Vivo Correlation (IVIVC), as defined by the FDA, is a predictive mathematical model describing the relationship between the in vitro property of a dosage form and relevant in vivo response. The FDA has provided little to no guidance on IVIVC practices, but there is growing interest including an FDA draft guidance using IVIVC methods for a generic drug development.

A basic system is comprised of two more-realistic elements to give a more accurate representation of how a drug may behave in a specific type of patient’s respiratory system: the first is a more anatomically representative mouth and throat feature, and the second is a more representative breathing pattern. 

The widely accepted industry standard for more-anatomically correct mouth and throat geometry, the Alberta Idealized Throat (AIT), comes in variations from child to adult.

Replicating a given patient populations' breathing patterns, such as COPD or asthma, is a bit more complicated, requiring a breathing simulator, additional compressed air source, air regulators, mixing inlet and several smaller components. The breathing simulator allows highly customizable inhalation and exhalation profiles, meaning  we are no longer constrained by square waves, as most in vitro air flow equipment is designed to create. This allows a repeatable test system to be able to more closely replicate patients’ systems and how a drug will be delivered.

The In Vitro – In Vivo correlation (IVIVC) philosophy is an important, yet simple, step towards reducing cost and risk going into clinic trials. In the grand scheme of development and clinical trial for Orally Inhaled & Nasal Drug Products (OINDP), IVIVC is a relatively low cost investment, usually using several pre-existing pieces of equipment.

Also, a developing area for IVIVC is in dissolution testing for OINDPs. There are general ways to approach this method of testing using a paddle-over-disc (with a special membrane) method to replicate lung absorption.

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