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IN VITRO-IN VIVO CORRELATION

The in vitro-in vivo correlation (IVIVC) is a scientific approach to describe the relationship between an in vitro property of a dosage form (e.g., the rate or extent of drug release) and a relevant in vivo response (e.g., plasma drug concentration or amount of drug absorbed). This resulting mathematical model is then used to predict the performance change from a modified product.

An IVIVC is a very important step in the development and submission of an extended release product. Both the FDA and EMEA recommend to develop the product specific IVIVC in the expectation that the information will be useful in establishing dissolution specifications and will permit formulation and manufacturing changes without an in vivo bioequivalence study.


BioVista has a wide experience in the development and validation of the IVIVC, as well in the design of studies for generation such a relationship.


Our IVIVC services include:

Analysis of your available in vitro and in vivo data for the feasibility of an acceptable IVIVC
Design and analysis of clinical studies possibly needed for generating the IVIVC
Assistance in the optimization of your in vitro dissolution system to be a predictor of in vivo performance, i.e. selection of a biorelevant and discriminating method
Development and validation of Level A and Level C IVIVC models, including linear and nonlinear models
Setting biopharmaceutically meaningful in vitro dissolution specifications using the IVIVC
Preparation of an IVIVC report to support a regulatory submission for:
- Initial approval process
- Post-approval changes (Level 3 changes or Type II variations)
- Obtaining a biowaiver for additional strengths, line extensions,
product modifications during scale-up
Negotiating the acceptance of the IVIVC with Health Authorities in advance or after submission
Holding an in house seminar on the principles and opportunities regarding an IVIVC




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