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

• Main Authors: Paulo Paixão (Author), Nuno Silva (Author), Rita Bento Guerreiro (Author), Kevin Blake (Author), Milton Bonelli (Author), José Augusto Guimarães Morais (Author), Alfredo García-Arieta (Author), Luís Filipe Gouveia (Author)
• Format: Book
• Published: MDPI AG, 2022-10-01T00:00:00Z.
• Subjects: article
• Online Access: 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...