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

• Main Authors: Paulo Paixao (Author), Alfredo Garcia Arieta (Author), Nuno Silva (Author), Zvonimir Petric (Author), Milton Bonelli (Author), José Augusto Guimarães Morais (Author), Kevin Blake (Author), Luís Filipe Gouveia (Author)
• Format: Book
• Published: MDPI AG, 2024-04-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

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...