Impact of Mechanistic Modeling and Simulation Methodologies on Product-Specific Guidance Development for Non-Orally Administered Drug Products.

ABSTRACT: The U.S. Food and Drug Administration (FDA) publishes product-specific guidances (PSGs), with bioequivalence (BE) recommendations for prospective generics. Developing BE recommendations for non-orally administered drug products including long-acting injectables (LAI), orally inhaled drug products, and drugs applied locally to the skin, ophthalmic, and nasal routes may be challenging because conventional BE methods and considerations for orally administered drug products may not apply. Mechanistic modeling approaches such as physiologically based pharmacokinetic (PBPK) models or computational fluid dynamics (CFD) models are used for the development of BE methods and BE assessment standards in PSGs for non-orally administered drug products, as evidenced by cases provided here. This manuscrip

SUBMITTER: Chopski SG 

PROVIDER: S-EPMC12439276 | biostudies-literature | 2025 Sep

REPOSITORIES: biostudies-literature