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...

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Detalles Bibliográficos
Autores principales: Tan, Ming‐Liang, Chandran, Sajeev, Jereb, Rebeka, Alam, Khondoker, Bies, Robert, Kozak, Darby, Walenga, Ross, Le Merdy, Maxime, Babiskin, Andrew
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2023
Materias:
Reviews
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

Internet

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

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