Encontrados 2 documentos, a visualizar página 1 de 1
Bioavailability and Bioequivalence: Meaning, Origin and Scientific, Pharmaceuti...
Paixão, Paulo; Silva, Nuno Elvas; Lobato, Maria do Rosário; Guimarães Morais, José A.This article intends to focus on the meaning, origin and use (scientific, pharmaceutical and regulatory) of the concepts underlying the following related terms: Bioavailability, Biogalenics and Bioequivalence. The aim is to provide a historical perspective on the evolution of these concepts in terms of improving their definitions, the underlying science and their acceptance and use by the scientific community, ...
The new European Medicines Agency Guideline on the investigation of bioequivalence
Morais, José A. G.; Lobato, Maria do RosárioIn this MiniReview, the main modifications made during the revision of the current Note for Guidance on the Investigation of Bioavailability and Bioequivalence are reviewed and justified. Several new features have been added to this guideline, as well as changes aimed at improving the clarity of the guidance provided. The first issue to be addressed was to limit the scope of the guideline to bioequivalence stud...