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

• Váldodahkkit: Paulo Paixão (Dahkki), Nuno Silva (Dahkki), Rita Bento Guerreiro (Dahkki), Kevin Blake (Dahkki), Milton Bonelli (Dahkki), José Augusto Guimarães Morais (Dahkki), Alfredo García-Arieta (Dahkki), Luís Filipe Gouveia (Dahkki)
• Materiálatiipa: Girji
• Almmustuhtton: MDPI AG, 2022-10-01T00:00:00Z.
• Fáttát: article
• Liŋkkat: Connect to this object online.

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 ca...