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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...
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 |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer International Publishing
2020
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Materias: | |
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 |
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