Alternative Pharmacokinetic Metrics in Single-Dose Studies to Ensure Bioequivalence of Prolonged-Release Products at Steady State—A Case Study

(1) Background: this article investigates which PK metrics in a single-dose study (concentration at the end of posology interval, C(τ), partial areas under the curve, pAUCs, or half-value duration, HVD) are more sensitive and less variable for predicting the failure of a prolonged-release product at...

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Detalles Bibliográficos
Autores principales: Mangas-Sanjuán, Víctor, Simón, Marta, González-Rojano, Esperanza, Ochoa, Dolores, Abad-Santos, Francisco, Román, Manuel, Ramos, Mercedes, Govantes, Carlos, García-Arieta, Alfredo
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2023
Materias:
Article
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9963605/
https://www.ncbi.nlm.nih.gov/pubmed/36839731
http://dx.doi.org/10.3390/pharmaceutics15020409

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9963605/
https://www.ncbi.nlm.nih.gov/pubmed/36839731
http://dx.doi.org/10.3390/pharmaceutics15020409

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