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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Detalhes bibliográficos
Publicado no:AAPS PharmSciTech
Main Authors: 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: Artigo
Idioma:Inglês
Publicado em: Springer International Publishing 2020
Assuntos:
Research Article
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC7266804/
https://ncbi.nlm.nih.gov/pubmed/32488427
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1208/s12249-020-01662-8
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