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Using IVIVC to Optimize Your Drug Formulation After a Failed BA/BE Study

20180718
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Bioequivalence (BE) trials are used to show that a new treatment is identical (within an acceptable range) to a current treatment. Comparative bioavailability (BA) studies are used, in the case of pilot studies, to select the best candidate for the pivotal BE study. BE studies are used in the registration and approval of generic drugs that are shown to be bioequivalent to their branded reference drugs. BE studies can also be required for pharmaceutical variations made to drugs. These pharmaceutical variations might include changes in manufacturing site, raw material suppliers, or minor changes in formulation.

To show bioequivalence, you must demonstrate similarity of the systemic drug levels expressed as extent (AUC) and rate (Cmax). The 90% confidence intervals of the ratio of AUC and Cmax of the generic drug to name-brand drug must lie between 80-125%.

But, what if your BE or BA study was a failure? Now what?

This webinar will introduce how in vitro-in vivo correlation (IVIVC) can be used to get your drug program back on track! An IVIVC is a predictive mathematical model describing the relationship between the in vitro properties of a dosage form and the in vivo responses. By attending this webinar, you will gain an appreciation of the following:

  • How to analyze the failed BE study
  • How to use IVIVC to:
    • Explore better dissolution tests
    • Predict your target dissolution to meet the reference
    • Optimize your drug’s formulation

About Our Speaker

Jean-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 Bio-pharmaceutical, 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.

Bioequivalence (BE) trials are used to show that a new treatment is identical (within an acceptable range) to a current treatment. Comparative bioavailability (BA) studies are used, in the case of pilot studies, to select the best candidate for the pivotal BE study. BE studies are used in the registration and approval of generic drugs that are shown to be bioequivalent to their branded reference drugs. BE studies can also be required for pharmaceutical variations made to drugs. These pharmaceutical variations might include changes in manufacturing site, raw material suppliers, or minor changes in formulation.

To show bioequivalence, you must demonstrate similarity of the systemic drug levels expressed as extent (AUC) and rate (Cmax). The 90% confidence intervals of the ratio of AUC and Cmax of the generic drug to name-brand drug must lie between 80-125%.

But, what if your BE or BA study was a failure? Now what?

This webinar introduced how in vitro-in vivo correlation (IVIVC) can be used to get your drug program back on track! An IVIVC is a predictive mathematical model describing the relationship between the in vitro properties of a dosage form and the in vivo responses. By watching this webinar, you will gain an appreciation of the following:

  • How to analyze the failed BE study
  • How to use IVIVC to:
    • Explore better dissolution tests
    • Predict your target dissolution to meet the reference
    • Optimize your drug’s formulation
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