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A Two-Way Proposal for the Determination of Bioequivalence for Narrow Therapeutic Index Drugs in the European Union

In the European Union, bioequivalence (BE) for narrow therapeutic index (NTI) drugs is currently demonstrated when the 90% confidence interval for the ratio of the population geometric means of the test and reference products for AUC, and in some cases for Cmax, falls within the acceptance range of...

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Autors principals: Paulo Paixao, Alfredo Garcia Arieta, Nuno Silva, Zvonimir Petric, Milton Bonelli, José Augusto Guimarães Morais, Kevin Blake, Luís Filipe Gouveia
Format: Artigo
Idioma:Inglês
Publicat: MDPI AG 2024-04-01
Col·lecció:Pharmaceutics
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Accés en línia:https://www.mdpi.com/1999-4923/16/5/598
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