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Mechanistic modeling of ophthalmic, nasal, injectable, and implant generic drug products: A workshop summary report
For approval, a proposed generic drug product must demonstrate it is bioequivalent (BE) to the reference listed drug product. For locally acting drug products, conventional BE approaches may not be feasible because measurements in local tissues at the sites of action are often impractical, unethical...
| Autores principales: | , , , , , , , , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
| Publicado: |
John Wiley and Sons Inc.
2023
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| Materias: | |
| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10196416/ https://www.ncbi.nlm.nih.gov/pubmed/36851886 http://dx.doi.org/10.1002/psp4.12952 |