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In a recent Q&A session, experts from Nanopharm and Fluidda delved into the FDA’s product specific guidances for inhaled products, highlighting significant updates and the implications for the pharmaceutical industry.
Dr. Will Ganley of Nanopharm and Dr. Jan De Backer of Fluidda shared insights on the evolution of bioequivalence studies, emphasizing the shift towards alternative methods like computational fluid dynamics, PBPK modeling, and realistic in vitro studies. This discussion underscored the FDA’s openness to innovative approaches for generic drug approval, aiming to streamline the process while ensuring product efficacy and safety.
Key Highlights:
- FDA’s Recent PSG Updates: The session opened with an overview of the FDA’s latest PSG updates, which introduced alternative bioequivalence methods for inhaled products. These updates mark a departure from traditional studies, incorporating advanced techniques like computational fluid dynamics and PBPK modeling.
- Alternative Bioequivalence Methods: The experts discussed the significance of these alternative methods, which offer a more nuanced understanding of drug behavior in the respiratory system. This approach is particularly relevant for locally acting products, where traditional bioequivalence measures may not fully capture the drug’s efficacy.
- In Silico Methods and Patient-Specific Data: Dr. De Backer highlighted Fluidda’s work in leveraging patient-specific data and in silico methods to simulate drug deposition in the lungs. This technology has evolved significantly, offering a more accurate representation of clinical scenarios and potentially accelerating the approval process for generic drugs.
- Charcoal Block PK Studies: The inclusion of charcoal block PK studies in the PSGs was discussed as a novel approach for measuring total lung dose. This method can help differentiate between inhaled and swallowed drug fractions, providing a clearer picture of drug distribution.
