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15:28
YouTube
U.S. Food and Drug Administration
AGDD 2024 | D1S11 - Orally Inhaled Drug Product PSGs: Considerations for Using Modeling and Sim...
This presentation identified recent product-specific guidance (PSG) documents that include detailed language regarding the use of in silico modeling for orally inhaled drug products (OIDPs). The session listed potential roles for in silico studies within alternative bioequivalence (BE) approaches for OIDPs and described recent PSG ...
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