Search Results - "Morais, José Augusto Guimarães"

A Two-Way Proposal for the Determination of Bioequivalence for Narrow Therapeutic Index Drugs in the European Union by Paixao, Paulo, Garcia Arieta, Alfredo, Silva, Nuno, Petric, Zvonimir, Bonelli, Milton, Morais, José Augusto Guimarães, Blake, Kevin, Gouveia, Luís Filipe

“…In the European Union, bioequivalence (BE) for narrow therapeutic index (NTI) drugs is currently demonstrated when the 90% confidence interval for the ratio of…”
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Evaluation of a Proposed Approach for the Determination of the Bioequivalence Acceptance Range for Narrow Therapeutic Index Drugs in the European Union by Paixão, Paulo, Silva, Nuno, Guerreiro, Rita Bento, Blake, Kevin, Bonelli, Milton, Morais, José Augusto Guimarães, García-Arieta, Alfredo, Gouveia, Luís Filipe

“…Bioequivalence (BE) of products containing narrow therapeutic index (NTI) drugs in the European Union is currently established by demonstrating that the 90%…”
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The New European Medicines Agency Guideline on the Investigation of Bioequivalence by Morais, José Augusto Guimarães, Lobato, Maria do Rosário

“…:  In this MiniReview, the main modifications made during the revision of the current Note for Guidance on the Investigation of Bioavailability and…”
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A Proposed Approach for the Determination of the Bioequivalence Acceptance Range for Narrow Therapeutic Index Drugs in the European Union by Paixão, Paulo, Guerreiro, Rita Bento, Silva, Nuno, Blake, Kevin, Bonelli, Milton, Morais, Jose Augusto Guimarães, Garcia Arieta, Alfredo, Gouveia, Luis Filipe

“…The current regulatory criterion for bioequivalence of narrow therapeutic index (NTI) drugs in the European Union requires that the 90% confidence interval for…”
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