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

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