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Non-linear Time Scaling for IVIVC: Secrets from an Expert

On-Demand Webinar

In vitro-in vivo correlation (IVIVC) is a predictive mathematical tool that describes the relationship between an in vitro property of a drug dosage form and an in vivo pharmacokinetic response. IVIVCs generally employ linear time scaling. Yet sometimes, the IVIVC relationship is better described by a more complex function. For example, some drugs release in vivo at 2 different rates. The release rates for erodible matrices depends on the dosage form’s position in the intestine. For implants, the release rate changes as diffusion is followed by erosion.

If the in vitro test does not account for these possibilities, the in vitro dissolution may exhibit a different shape compared to in vivo release. In this case, a non-linear relationship must be established. Prof. JM Cardot will explain how non-parametric approaches can be used to determine time scaling.

About Our Speaker

Webinar-1speaker-CardotJean-Michel Cardot is a professor and head of the Department of Biopharmaceutics and Pharmaceutical Technology at the Auvergne University in France. Prior to coming to Auvergne University, he worked in the pharmaceutical industry for 15 years. Prof. Cardot earned degrees in pharmacy (PharmD), a Masters in Biopharmaceutical, Statistical sciences and Pharmacokinetics, and a doctorate in pharmaceutical sciences from Auvergne University. His research interests include biopharmaceutical development of drugs, in vitro dissolution, and in vivo bioequivalence and in vitro-in vivo correlation.

In vitro-in vivo correlation (IVIVC) is a predictive mathematical tool that describes the relationship between an in vitro property of a drug dosage form and an in vivo pharmacokinetic response. IVIVCs generally employ linear time scaling. Yet sometimes, the IVIVC relationship is better described by a more complex function. For example, some drugs release in vivo at 2 different rates. The release rates for erodible matrices depends on the dosage form’s position in the intestine. For implants, the release rate changes as diffusion is followed by erosion.

If the in vitro test does not account for these possibilities, the in vitro dissolution may exhibit a different shape compared to in vivo release. In this case, a non-linear relationship must be established. Prof. JM Cardot explained how non-parametric approaches can be used to determine time scaling.

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