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

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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Bibliographic Details
Main Authors: Paulo Paixão, Nuno Silva, Rita Bento Guerreiro, Kevin Blake, Milton Bonelli, José Augusto Guimarães Morais, Alfredo García-Arieta, Luís Filipe Gouveia
Format: Article
Language:English
Published: MDPI AG 2022-10-01
Series:Pharmaceutics
Subjects:
narrow therapeutic index
bioequivalence
medicines regulation
generic medicinal products
Online Access:https://www.mdpi.com/1999-4923/14/11/2349

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https://www.mdpi.com/1999-4923/14/11/2349

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