Physiologically Based Dissolution Testing in a Drug Development Process—a Case Study of a Successful Application in a Bioequivalence Study of Trazodone ER Formulations Under Fed Conditions

Development of generic extended-release (ER) formulations is challenging. Especially under fed conditions, the risk of failure in bioequivalence trials is high because of long gastric residence times and susceptibility to food effects. We describe the development of a generic trazodone ER formulatio...

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Detalles Bibliográficos
Autores principales: Danielak, Dorota, Milanowski, Bartłomiej, Wentowski, Krzysztof, Nogowska, Maria, Kątny, Michał, Rogowski, Piotr, Konwicki, Łukasz, Puk, Ewa, Pieczuro, Jarosław, Bawiec, Marek, Garbacz, Grzegorz, Lulek, Janina
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2020
Materias:
Research Article
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7266804/
https://www.ncbi.nlm.nih.gov/pubmed/32488427
http://dx.doi.org/10.1208/s12249-020-01662-8

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7266804/
https://www.ncbi.nlm.nih.gov/pubmed/32488427
http://dx.doi.org/10.1208/s12249-020-01662-8

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