FDA's use of Pharmaron's IDAS
Capabilities
An FDA-sponsored research project utilized Pharmaron’s proprietary IDAS (In vitro dissolution absorption system) to understand anti-oxidants use as a mitigation strategy.
20% of all API’s have an amine group which renders them susceptible to the formation of nitrosamine impurities. While this affects all drugs, it affects generic drugs disproportionately.
We presented these findings at the Center for Research on Complex Generics’ event, Mitigation Strategies for Nitrosamine Drug Substance Related Impurities: Quality and Bioequivalence Considerations for Generics. To view Pharmaron’s presentation at this FDA-hosted event, please visit the website to access slides and a recording of the event here.
IDAS, Pharmaron’s proprietary technology, combines traditional dissolution testing to determine and quantify interactions with a bio-relevant membrane. IDAS can evaluate absorption, permeation, accumulation, biomarker regulation, and metabolism and test a finished dosage form from a tablet or capsule to suspension.
Download Pharmaron’s IDAS brochure to learn how this technology can advance your next study.
Watch our IDAS2 Video:
Mitigation Strategies for Nitrosamine Drug Substance Related Impurities
IDAS Biopharmaceutics Dissolution with Better in vivo Correlation
