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

Metagenomic Insight into Microbiome and Antibiotic Resistance Genes of High Clinical Concern in Urban and Rural Hospital Wastewater of Northern India Origin: a Major Reservoir of A...

por Talat, Absar, Blake, Kevin S., Dantas, Gautam, Khan, Asad U.
Publicado 2023

Overview of the European Medicines Agency's Development of Product‐Specific Bioequivalence Guidelines

por Sullivan, Jane O', Blake, Kevin, Berntgen, Michael, Salmonson, Tomas, Welink, Jan
Publicado 2018

Overview of the European Medicines Agency's Experience With Biowaivers in Centralized Applications

por Lenić, Ines, Blake, Kevin, Garcia‐Arieta, Alfredo, Potthast, Henrike, Welink, Jan
Publicado 2019

Structure of anhydrotetracycline-bound Tet(X6) reveals the mechanism for inhibition of type 1 tetracycline destructases

por Kumar, Hirdesh, Williford, Emily E., Blake, Kevin S., Virgin-Downey, Brett, Dantas, Gautam, Wencewicz, Timothy A., Tolia, Niraj H.
Publicado 2023

Publisher Correction: Structure of anhydrotetracycline-bound Tet(X6) reveals the mechanism for inhibition of type 1 tetracycline destructases

por Kumar, Hirdesh, Williford, Emily E., Blake, Kevin S., Virgin-Downey, Brett, Dantas, Gautam, Wencewicz, Timothy A., Tolia, Niraj H.
Publicado 2023

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

A European multicentre drug utilisation study of the impact of regulatory measures on prescribing of codeine for pain in children

por Hedenmalm, Karin, Blake, Kevin, Donegan, Katherine, Macia, Miguel‐Angel, Gil, Miguel, Williams, Julie, Montero, Dolores, Candore, Gianmario, Morales, Daniel, Kurz, Xavier, Arlett, Peter
Publicado 2019

Using mechanistic models to support development of complex generic drug products: European Medicines Agency perspective

por Manolis, Efthymios, García‐Arieta, Alfredo, Lindahl, Anders, Kotzagiorgis, Evangelos, Limberg, Jobst, Holte, Øyvind, Paixao, Paulo, Versantvoort, Carolien, Tshinanu, Flora Musuamba, Blake, Kevin, Van Den Heuvel, Michiel
Publicado 2023

Impact of international travel and diarrhea on gut microbiome and resistome dynamics

por Boolchandani, Manish, Blake, Kevin S., Tilley, Drake H., Cabada, Miguel M., Schwartz, Drew J., Patel, Sanket, Morales, Maria Luisa, Meza, Rina, Soto, Giselle, Isidean, Sandra D., Porter, Chad K., Simons, Mark P., Dantas, Gautam
Publicado 2022