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Evaluation of a Proposed Approach for the Determination of the Bioequivalence Acceptance Range for Narrow Therapeutic Index Drugs in the European Union

Bioequivalence (BE) of products containing narrow therapeutic index (NTI) drugs in the European Union is currently established by demonstrating that the 90% confidence interval for the ratio of the population geometric means of the test compared to the reference product’s AUC, and in certain cases C...

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Detalles Bibliográficos
Autores principales:	Paixão, Paulo, Silva, Nuno, Guerreiro, Rita Bento, Blake, Kevin, Bonelli, Milton, Morais, José Augusto Guimarães, García-Arieta, Alfredo, Gouveia, Luís Filipe
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	MDPI 2022
Materias:	Article
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9697618/ https://www.ncbi.nlm.nih.gov/pubmed/36365166 http://dx.doi.org/10.3390/pharmaceutics14112349

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