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Authors whose works are in public domain in at least one jurisdiction

List of works by Marie Louise De Bruin

A decade of marketing approval of gene and cell-based therapies in the United States, European Union and Japan: An evaluation of regulatory decision-making

scientific article published on 02 May 2018

A qualitative study of biosimilar manufacturer and regulator perceptions on intellectual property and abbreviated approval pathways

scientific article published on 01 November 2020

Adjusting for unmeasured confounding using validation data: Simplified two-stage calibration for survival and dichotomous outcomes

scientific article published on 03 March 2019

Advanced therapy medicinal product manufacturing under the hospital exemption and other exemption pathways in seven European Union countries

scientific article published on 17 June 2020

Adverse Drug Reaction Reporting in Africa and a Comparison of Individual Case Safety Report Characteristics Between Africa and the Rest of the World: Analyses of Spontaneous Reports in VigiBase®

scientific article published on 11 January 2016

An analysis of marketing authorisation applications via the mutual recognition and decentralised procedures in Europe

scientific article

Ankylosing spondylitis and risk of ischaemic heart disease: a population-based cohort study

scientific article published on 31 October 2014

Anti-HERG activity and the risk of drug-induced arrhythmias and sudden death

scientific article published on 06 January 2005

Antidepressant prescribing in five European countries: application of common definitions to assess the prevalence, clinical observations, and methodological implications.

scientific article published on 03 May 2014

Are ECG monitoring recommendations before prescription of QT-prolonging drugs applied in daily practice? The example of haloperidol.

scientific article

Are Further Interventions Needed to Prevent and Manage Hospital-Acquired Hyponatraemia? A Nationwide Cross-Sectional Survey of IV Fluid Prescribing Practices

scientific article published on 29 August 2020

Are monitoring instructions provided in direct healthcare professional communications (DHPCs) of sufficient quality? A retrospective analysis of DHPCs sent out between 2007 and 2018

scientific article published on 11 May 2020

Benefit-risk reassessment of medicines: a retrospective analysis of all safety-related referral procedures in Europe during 2001-2012.

scientific article published on 4 May 2016

Body of evidence and approaches applied in the clinical development programme of fixed-dose combinations in the European Union from 2010 to 2016

scientific article published on 17 June 2019

Breast Cancer Risk After Radiation Therapy for Hodgkin Lymphoma: Influence of Gonadal Hormone Exposure

scientific article published on 18 July 2017

Breast cancer risk in female survivors of Hodgkin's lymphoma: lower risk after smaller radiation volumes

scientific article published on 10 August 2009

CARING (CAncer Risk and INsulin analoGues): the association of diabetes mellitus and cancer risk with focus on possible determinants - a systematic review and a meta-analysis

scientific article

Calcium channel blockers and cancer: a risk analysis using the UK Clinical Practice Research Datalink (CPRD).

scientific article

Cancer is associated with severe disease in COVID-19 patients: a systematic review and meta-analysis

scientific article published on 18 May 2020

Cancer risk among insulin users: comparing analogues with human insulin in the CARING five-country cohort study

scientific article published on June 2017

Cardiac arrhythmias in adult patients with asthma

scientific article published on 27 September 2012

Characteristics and follow-up of postmarketing studies of conditionally authorized medicines in the EU.

scientific article

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

scientific article

Comparing risk of major bleeding between users of different oral anticoagulants in patients with non-valvular atrial fibrillation

scientific article published on 06 July 2020

Data management and data analysis techniques in pharmacoepidemiological studies using a pre-planned multi-database approach: a systematic literature review.

scientific article

Diabetes and Breast Cancer Subtypes.

scientific article

Drug-induced progressive multifocal leukoencephalopathy: Lessons learned from contrasting natalizumab and rituximab.

scientific article published on 8 September 2015

EU decision-making for marketing authorization of advanced therapy medicinal products: a case study

scientific article published on 21 March 2018

Electrocardiographic characteristics of patients with chronic obstructive pulmonary disease

scientific article published on 01 February 2013

Epidemiology of adverse drug reactions in Europe: a review of recent observational studies

scientific article published on May 2015

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

scientific article published in January 2017

Exercise echocardiography in asymptomatic survivors of childhood cancer treated with anthracyclines: a prospective follow-up study

scientific article published on 01 April 2010

Exposure to benzodiazepines (anxiolytics, hypnotics and related drugs) in seven European electronic healthcare databases: a cross-national descriptive study from the PROTECT-EU Project.

scientific article

Fertility in female childhood cancer survivors.

scientific article published on 03 March 2009

Gastrointestinal cancer incidence in type 2 diabetes mellitus; results from a large population-based cohort study in the UK

scientific article published on 16 May 2018

Genetic susceptibility to radiation-induced breast cancer after Hodgkin lymphoma

scholarly article by Annemieke W J Opstal-van Winden et al published 7 March 2019 in Blood

Genetic, clinical and pharmacological determinants of out-of-hospital cardiac arrest: rationale and outline of the AmsteRdam Resuscitation Studies (ARREST) registry

scientific article

Global Regulatory Differences for Gene- and Cell-Based Therapies: Consequences and Implications for Patient Access and Therapeutic Innovation.

scientific article published on 6 October 2017

Glucose-lowering agents and the patterns of risk for cancer: a study with the General Practice Research Database and secondary care data.

scientific article

Hospital discharge diagnoses of ventricular arrhythmias and cardiac arrest were useful for epidemiologic research.

scientific article

In-hospital cardiac arrest is associated with use of non-antiarrhythmic QTc-prolonging drugs

scientific article

Incidence Rates and Trends of Hip/Femur Fractures in Five European Countries: Comparison Using E-Healthcare Records Databases

article

Incidence of adverse events among healthcare workers following H1N1 Mass immunization in Ghana: a prospective study.

scientific article published on April 2013

Incidence of direct oral anticoagulant use in patients with nonvalvular atrial fibrillation and characteristics of users in 6 European countries (2008-2015): A cross-national drug utilization study

scientific article published on 04 September 2019

Increased risk of stroke and transient ischemic attack in 5-year survivors of Hodgkin lymphoma

scientific article published on 17 June 2009

Increased risk of sudden cardiac arrest in obstructive pulmonary disease: a case-control study

scientific article (publication date: 2013)

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

scientific article

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

Infradiaphragmatic irradiation and high procarbazine doses increase colorectal cancer risk in Hodgkin lymphoma survivors.

scientific article published on 20 June 2017

Insulin glargine use and breast cancer risk: Associations with cumulative exposure

scientific article published on 06 May 2016

Intensive glucose control and risk of cancer in patients with type 2 diabetes

scientific article published on 21 April 2011

Late cardiotoxicity after treatment for Hodgkin lymphoma

scientific article published on 21 November 2006

Lessons learned on the design and the conduct of Post-Authorization Safety Studies: review of 3 years of PRAC oversight.

scientific article

Long-term use of 5α-reductase inhibitors and the risk of male breast cancer

scientific article published on 19 August 2014

Malignant mesothelioma after radiation treatment for Hodgkin lymphoma

scientific article published on 20 February 2009

Number of patients studied prior to approval of new medicines: a database analysis

scientific article

Pharmacogenetics of drug-induced arrhythmias: a feasibility study using spontaneous adverse drug reactions reporting data

scientific article

Poor adherence and persistence to sodium glucose co-transporter 2 inhibitors in real world settings: evidence from a systematic review and meta-analysis

scientific article published on 24 May 2020

Postauthorization Changes to Specific Obligations of Conditionally Authorized Medicines in the European Union: A Retrospective Cohort Study

scientific article published on 12 August 2018

Predicting Cardiac Arrhythmias and Sudden Death in Diabetic Users of Proarrhythmic Drugs

scientific article published on 01 February 2005

Publication rates and reported results in a cohort of gene- and cell-based therapy trials

scientific article published on 01 January 2020

QT Interval Prolongation in Users of Selective Serotonin Reuptake Inhibitors in an Elderly Surgical Population

scientific article published on 01 January 2014

QTc-prolonging drugs and hospitalizations for cardiac arrhythmias.

scientific article

Quality of drug label information on QT interval prolongation

scientific article published on 01 January 2014

Radiation-associated breast tumors display a distinct gene expression profile

scientific article

Randomized controlled trials of COX-2 inhibitors: an analysis of doses used and trends over time to investigate implications for comparative safety.

scientific article

Re: Late effects from radiation therapy: the hits just keep on coming

scientific article published on 22 March 2010

Re: nonsteroidal anti-inflammatory drug use, chronic liver disease, and hepatocellular carcinoma.

scientific article

Reduced in-hospital survival rates of out-of-hospital cardiac arrest victims with obstructive pulmonary disease

scientific article published on 17 October 2012

Registries in European post-marketing surveillance: a retrospective analysis of centrally approved products, 2005-2013.

scientific article published on 26 March 2017

Regulating advanced therapy medicinal products through the Hospital Exemption: an analysis of regulatory approaches in nine EU countries

scientific article published on 05 November 2020

Resting heart rate is a risk factor for mortality in chronic obstructive pulmonary disease, but not for exacerbations or pneumonia

scientific article

Risk Management Plans as a Tool for Proactive Pharmacovigilance: A Cohort Study of Newly Approved Drugs in Europe

scientific article published on 15 September 2014

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

scientific article published on June 2015

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

scientific article

Safety information on QT-interval prolongation: comparison of European Union and United States drug labeling

scientific article published on 25 June 2014

Safety learning from drugs of the same class: room for improvement.

scientific article published on 28 March 2012

Serum selenium, vitamin antioxidants, and cardiovascular mortality: a 9-year follow-up study in the Netherlands

scientific article published on 01 February 1987

Smoking cessation strategies in patients with COPD ⬇️

scientific article published on August 30, 2012

Strategy in Regulatory Decision-Making for Management of Progressive Multifocal Leukoencephalopathy.

scientific article published on 06 August 2015

The Costs and Effects of Post-Authorisation Safety Studies For New Active Substances

scientific article published on 26 October 2014

The EU regulatory landscape of non-biological complex drugs (NBCDs) follow-on products: Observations and recommendations

scientific article published on 03 April 2019

The association of diabetes mellitus and insulin treatment with expression of insulin-related proteins in breast tumors

scientific article published on 27 February 2018

The effect of exposure misclassification in spontaneous ADR reports on the time to detection of product-specific risks for biologicals: a simulation study.

scientific article published on 16 December 2015

The effectiveness of direct to healthcare professional communication - A systematic review of communication factor studies

scientific article published on 21 June 2018

The epidemiology of extra-articular manifestations in ankylosing spondylitis: a population-based matched cohort study

scientific article published on 21 March 2014

The post hoc use of randomised controlled trials to explore drug associated cancer outcomes: methodological challenges

scientific article

The risk of acute liver injury associated with the use of antibiotics--evaluating robustness of results in the pharmacoepidemiological research on outcomes of therapeutics by a European consortium (PROTECT) project

scientific article published on 2 August 2015

The risk of colorectal cancer in patients with type 2 diabetes: associations with treatment stage and obesity

scientific article published on 31 December 2014

The risk of venous thromboembolism in patients with multiple sclerosis: the Clinical Practice Research Datalink

scientific article published on 01 April 2014

Traceability of Biologics in The Netherlands: An Analysis of Information-Recording Systems in Clinical Practice and Spontaneous ADR Reports

scientific article published on 30 December 2015

Traceability of Biopharmaceuticals in Spontaneous Reporting Systems: A Cross-Sectional Study in the FDA Adverse Event Reporting System (FAERS) and EudraVigilance Databases

scientific article published on 01 August 2013

Traceability of biologicals: present challenges in pharmacovigilance

scientific article

Treatment with insulin (analogues) and breast cancer risk in diabetics; a systematic review and meta-analysis of in vitro, animal and human evidence

scientific article

Treatment-related risk factors for premature menopause following Hodgkin lymphoma.

scientific article published on 21 September 2007

Trends in breast cancer incidence among women with type-2 diabetes in British general practice.

scientific article

Understanding inconsistency in the results from observational pharmacoepidemiological studies: the case of antidepressant use and risk of hip/femur fractures

scientific article published on March 2016

Use of cisapride with contraindicated drugs in The Netherlands

scientific article published in February 2002

Use of incretin agents and risk of acute and chronic pancreatitis: A population-based cohort study

scientific article published on 24 November 2016

Use of incretin agents and risk of pancreatic cancer: a population-based cohort study.

scientific article published on 5 November 2015

Use of insulin and insulin analogs and risk of cancer - systematic review and meta-analysis of observational studies.

scientific article

Use of metformin and survival of diabetic women with breast cancer

scientific article

Use of sympathomimetic drugs leads to increased risk of hospitalization for arrhythmias in patients with congestive heart failure

scientific article published on 01 September 2000

Use of the conditional marketing authorization pathway for oncology medicines in Europe.

scientific article

Use of thiazolidinediones and risk of bladder cancer: disease or drugs?

scientific article published on 01 November 2013

Validity of diagnostic codes and laboratory measurements to identify patients with idiopathic acute liver injury in a hospital database

scientific article published on 05 July 2015

When more is less - An exploratory study of the precautionary reporting bias and its impact on safety signal detection.

scientific article published on 15 September 2017

[Research into the risk of malignancy from biologicals: utility of meta-analysis hampered]

scientific article published on 01 January 2013

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