Mandatory requirements for pediatric drug development in the EU and the US for novel drugs—A comparative study

por Christiansen, Helle, De Bruin, Marie L., Hallgreen, Christine E.
Publicado 2022

Epidemiology of Adverse Drug Reactions in Europe: A Review of Recent Observational Studies

por Bouvy, Jacoline C., De Bruin, Marie L., Koopmanschap, Marc A.
Publicado 2015

Pharmacogenetic‐Pharmacokinetic Interactions in Drug Marketing Authorization Applications via the European Medicines Agency Between 2014 and 2017

por Maliepaard, Marc, Toiviainen, Timi, De Bruin, Marie L., Meulendijks, Didier
Publicado 2020

Improving Interactions Between Health Technology Assessment Bodies and Regulatory Agencies: A Systematic Review and Cross-Sectional Survey on Processes, Progress, Outcomes, and Cha...

por Ofori-Asenso, Richard, Hallgreen, Christine E., De Bruin, Marie Louise
Publicado 2020

Surveillance of Antidepressant Safety (SADS): Active Signal Detection of Serious Medical Events Following SSRI and SNRI Initiation Using Big Healthcare Data

por Aakjær, Mia, De Bruin, Marie Louise, Kulahci, Murat, Andersen, Morten
Publicado 2021

Classification of Recombinant Biologics in the EU: Divergence Between National Pharmacovigilance Centers

por Klein, Kevin, De Bruin, Marie L., Broekmans, Andre W., Stolk, Pieter
Publicado 2015

Guidance for pediatric use in prescription information for novel medicinal products in the EU and the US

por Christiansen, Helle, De Bruin, Marie L., Frokjaer, Sven, Hallgreen, Christine E.
Publicado 2022

Serious arrhythmia in initiators of citalopram, escitalopram, and other selective serotonin reuptake inhibitors: A population‐based cohort study in older adults

por Aakjær, Mia, Werther, Sarah Kimmer, De Bruin, Marie Louise, Andersen, Morten
Publicado 2022

Are monitoring instructions provided in direct healthcare professional communications (DHPCs) of sufficient quality? A retrospective analysis of DHPCs sent out between 2007 and 201...

por Højer, Maja-Marie Grønfeldt, De Bruin, Marie Louise, Boskovic, Arnela, Hallgreen, Christine Erikstrup
Publicado 2020

Influence of metformin intake on the risk of bladder cancer in type 2 diabetes patients

por Goossens, Maria (Mieke), Buntinx, Frank, Zeegers, Maurice, Driessen, Annemariek, De Bruin, Marie, De Vries, Frank
Publicado 2015

Risk of bladder cancer in patients with diabetes: a retrospective cohort study

por Goossens, Maria (Mieke), Zeegers, Maurice, Bazelier, Marloes, De Bruin, Marie, Buntinx, Frank, De Vries, Frank
Publicado 2015

Use of Real‐World Data and Evidence in Drug Development of Medicinal Products Centrally Authorized in Europe in 2018–2019

por Eskola, Sini Marika, Leufkens, Hubertus Gerardus Maria, Bate, Andrew, De Bruin, Marie Louise, Gardarsdottir, Helga
Publicado 2021

Impact of a Treatment Guide on Intravenous Fluids in Minimising the Risk of Hospital-Acquired Hyponatraemia in Denmark

por Sindahl, Per, Overgaard-Steensen, Christian, Wallach-Kildemoes, Helle, De Bruin, Marie Louise, Kemp, Kaare, Gardarsdottir, Helga
Publicado 2023

Resting Heart Rate Is a Risk Factor for Mortality in Chronic Obstructive Pulmonary Disease, but Not for Exacerbations or Pneumonia

por Warnier, Miriam J., Rutten, Frans H., de Boer, Anthonius, Hoes, Arno W., De Bruin, Marie L.
Publicado 2014

Evidence Synthesis in Harm Assessment of Medicines Using the Example of Rosiglitazone and Myocardial Infarction

por Rietbergen, Charlotte, Stefansdottir, Gudrun, Leufkens, Hubert G., Knol, Mirjam J., De Bruin, Marie L., Klugkist, Irene
Publicado 2018

Impact of regulatory interventions to restrict the combined use of renin–angiotensin system blockers: A Danish nationwide drug utilisation study

por Sindahl, Per, Ofori‐Asenso, Richard, Hallgreen, Christine Erikstrup, Kemp, Kaare, Gardarsdottir, Helga, De Bruin, Marie Louise
Publicado 2021

Challenges and Opportunities for Companies to Build HTA/Payer Perspectives Into Drug Development Through the Use of a Dynamic Target Product Profile

por Wang, Ting, McAuslane, Neil, Goettsch, Wim G., Leufkens, Hubert G. M., De Bruin, Marie L.
Publicado 2022

Risk of bladder cancer in patients with diabetes: a retrospective cohort study

por Goossens, Maria E, Zeegers, Maurice P, Bazelier, Marloes T, De Bruin, Marie L, Buntinx, Frank, de Vries, Frank
Publicado 2015

Duration of Effectiveness Evaluation of Additional Risk Minimisation Measures for Centrally Authorised Medicinal Products in the EU Between 2012 and 2021

por Essink, Sharon C. M., Zomerdijk, Inge M., Straus, Sabine M. J. M., Gardarsdottir, Helga, De Bruin, Marie L.
Publicado 2023

Investigation of the potential association between the use of fluoxetine and occurrence of acute pancreatitis: a Danish register-based cohort study

por Aakjær, Mia, Kristiansen, Sarah Brøgger, Pape, Kathrine, Sessa, Maurizio, Dalhoff, Kim Peder, De Bruin, Marie Louise, Andersen, Morten
Publicado 2022