Scientific and regulatory activities initiated by the U.S. Food and drug administration to foster approvals of generic dry powder inhalers: Bioequivalence perspective

Increasing impact of quantitative methods and modeling in establishment of bioequivalence and characterization of drug delivery

“…Specifically, detailed MIE case studies representing the FDA's current thinking and expectations on MIE for regulatory applications, can be effectively disseminated through organizing workshops and other communication means, in addition to scientific publications. We note that the FDA is dedicated to actively publishing the progresses and case examples of MIE from the GDUFA research and there are several publications in the complex products including orally inhaled, long‐acting injectable/implant, and dermal products 5–8 . In addition, we believe that this special issue will provide a useful summary of the most recent development and discussion around the application of MIE to generic drug product development and assessment.…”

“…We note that the FDA is dedicated to actively publishing the progresses and case examples of MIE from the GDUFA research and there are several publications in the complex products including orally inhaled, long-acting injectable/implant, and dermal products. [5][6][7][8] In addition, we believe that this special issue will provide a useful summary of the most recent development and discussion around the application of MIE to generic drug product development and assessment. The annual GDUFA science and research reports are another resource to check out the progress in MIE, which include a summary of research activities, research highlights, comprehensive lists of new, ongoing, and completed grants and contracts, and outcomes generated from the GDUFA-funded science and research program in each fiscal year.…”

Inhaled Corticosteroids: Benefits and Risks

“…Regarding fluticasone, according to the manufacturer's summary of Product Characteristics, FF 100 μg once daily is approximately equivalent to FP 250 μg twice daily [35]. The devices nowadays are many, especially those designed to deliver the DPI either pre-metered or device-metered (Figure 2) [36].…”