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- Model-integrated evidence (MIE) refers to using model generated information such as the virtual bioequivalence (VBE) study results not just to plan a pivotal study but to serve as critical evidence
Sep 12, 2023 · Prospective generic drug applicants and generic drug applicants who intend to use model-integrated evidence (MIE) approaches for bioequivalence (BE) establishment in their abbreviated new...
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What is model-integrated evidence (Mie) for bioequivalence?
Can model-integrated evidence demonstrate bioequivalence for long-acting injectable and implantable drugs?
Can Mie be used for bioequivalence assessment of Lai products?
What will FDA discuss during the Mie meeting pilot program?
Dec 5, 2023 · On October 1, 2023, FDA launched a new pilot offering meeting opportunities to prospective generic drug applicants and generic drug applicants who intend to use Model-Integrated Evidence...
Model-integrated evidence (MIE) refers to using model generated information such as the virtual bioequivalence (VBE) study results not just to plan a pivotal study but to serve as critical...
Nov 10, 2021 · • Model-Integrated Evidence approach provides opportunity to save time and resources in development of Long-Acting Injectable Products. • FDA supports innovative alternative approaches to demonstrate bioequivalence to overcome challenges in generic drug development and assessment.
May 9, 2022 · Model-integrated evidence (MIE) refers to using model generated information such as the virtual bioequivalence (VBE) study results not just to plan a pivotal study but to serve as pivotal evidence www.fda.gov
Oct 13, 2023 · FDA's generic drug program launched a new pilot program to offer meeting opportunities to generic drug applicants who intend to use model-integrated evidence (MIE) approaches to establish bioequivalence (BE) in their abbreviated new drug applications (ANDAs).
Jan 29, 2023 · This workshop brought relevant parties from the industry, academia, and the FDA in the field of modeling and simulation to explore, identify, and recommend best practices on utilizing MIE for bioequivalence (BE) assessment of LAI products.
