Promoting Safe Early Clinical Research of Novel Drug Candidates: A European Union Regulatory Perspective

por Ponzano, Stefano, Blake, Kevin, Bonelli, Milton, Enzmann, Harald
Publicado 2017

Towards a better use of scientific advice for developers of advanced therapies

por Tavridou, Anna, Rogers, Dolca, Bonelli, Milton, Schiel, Anja, Hidalgo‐Simon, Ana
Publicado 2020

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

por Paixão, Paulo, Silva, Nuno, Guerreiro, Rita Bento, Blake, Kevin, Bonelli, Milton, Morais, José Augusto Guimarães, García-Arieta, Alfredo, Gouveia, Luís Filipe
Publicado 2022