Science & Research

Innovations in Regulatory Science In Vivo Predictive Dissolution (IPD) to Advance Oral Product Bioequivalence (BE) Regulation

Performer: University of Nottingham and College of Pharmacy, University of Michigan

Principal Investigator: Gordon Amidon, Luca Marciani

Project Duration: 9/30/2015-9/28/2017

Regulatory Science Challenge

Pharmaceutical drug products require standards and tests in order to ensure therapeutic effectiveness in patients. Manufacturing and components in drug products undergo continuous change as science and technology evolves and advances. Thus, there is a need to establish pharmaceutical product tests and standards to ensure that patients are receiving the effective doses established for drugs in clinical trials. The main standards to ensure this are based on expensive bioequivalence (BE) testing in humans. A substitute for this type of testing has been recently developed and implemented for selected type of drugs. This new method can be performed routinely on each batch of drug product, does not unnecessarily expose human subjects to drugs with potential side effects, and can be quickly implemented, performed, and evaluated.

Project Description & Goals

The study proposes to extend the new method mentioned above and incorporate the most recent advances in gastroenterology, imaging technology such as magnetic resonance imaging (MRI), and computational analysis to develop new regulatory bioequivalence evaluation standards for ensuring safety, efficacy, and consistent therapeutic performance of oral drug products, which are the most commonly prescribed pharmaceutical products worldwide. This advanced approach to oral pharmaceutical products will reduce and simplify oral drug product tests and significantly reduce the regulatory burden to the pharmaceutical industry while increasing product therapeutic quality. In addition, the methods will allow the pharmaceutical industry to adapt more quickly to changes in oral product manufacturing technologies. These advances will significantly enhance oral pharmaceutical product design and optimization and serve as a strong scientific basis for the FDA in modernizing and setting regulations.

Page Last Updated: 09/11/2017
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