Hubert G Leufkens

Hubert G M Leufkens

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Hubert G Leufkens

Hubert G M Leufkens

Publications by authors named "Hubert G M Leufkens"

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1PubMed Central Citations

Unmet Medical Need: An Introduction to Definitions and Stakeholder Perceptions.

Value Health 2019 Nov 6;22(11):1275-1282. Epub 2019 Sep 6.

Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands; National Health Care Institute, Diemen, The Netherlands. Electronic address:

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http://dx.doi.org/10.1016/j.jval.2019.07.007DOI Listing
November 2019

Phase I/II Clinical Trial-Based Early Economic Evaluation of Acalabrutinib for Relapsed Chronic Lymphocytic Leukaemia.

Appl Health Econ Health Policy 2019 Jul 18. Epub 2019 Jul 18.

Erasmus School of Health Policy and Management, Erasmus University Rotterdam, Rotterdam, The Netherlands.

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http://dx.doi.org/10.1007/s40258-019-00496-1DOI Listing
July 2019

Tenofovir-associated renal toxicity in a cohort of HIV infected patients in Ghana.

BMC Res Notes 2019 Jul 22;12(1):445. Epub 2019 Jul 22.

Department of Medicine, University of Ghana School of Medicine and Dentistry, P. O. Box GP 4236, Accra, Ghana.

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http://dx.doi.org/10.1186/s13104-019-4454-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6647254PMC
July 2019

Potentially inappropriate medications with risk of cardiovascular adverse events in the elderly: A systematic review of tools addressing inappropriate prescribing.

J Clin Pharm Ther 2019 Jun 11;44(3):349-360. Epub 2019 Feb 11.

Centro de Investigação Interdisciplinar Egas Moniz (CiiEM), Instituto Universitário Egas Moniz, Caparica, Portugal.

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http://dx.doi.org/10.1111/jcpt.12811DOI Listing
June 2019

Post-marketing dosing changes in the label of biologicals.

Br J Clin Pharmacol 2019 04 16;85(4):715-721. Epub 2019 Feb 16.

Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, Utrecht, The Netherlands.

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http://dx.doi.org/10.1111/bcp.13843DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6422665PMC
April 2019

Weighing of Evidence by Health Technology Assessment Bodies: Retrospective Study of Reimbursement Recommendations for Conditionally Approved Drugs.

Clin Pharmacol Ther 2019 Mar 8;105(3):684-691. Epub 2018 Nov 8.

Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, Utrecht, The Netherlands.

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http://doi.wiley.com/10.1002/cpt.1251
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http://dx.doi.org/10.1002/cpt.1251DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6587700PMC
March 2019

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

Clin Pharmacol Ther 2019 02 12;105(2):426-435. Epub 2018 Aug 12.

Innovation Studies, Copernicus Institute of Sustainable Development, Utrecht University, Utrecht, The Netherlands.

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http://dx.doi.org/10.1002/cpt.1169DOI Listing
February 2019

Challenges in Advanced Therapy Medicinal Product Development: A Survey among Companies in Europe.

Mol Ther Methods Clin Dev 2018 Dec 11;11:121-130. Epub 2018 Oct 11.

Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, Universiteitsweg 99, 3584 CG Utrecht, the Netherland.

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https://linkinghub.elsevier.com/retrieve/pii/S23290501183009
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http://dx.doi.org/10.1016/j.omtm.2018.10.003DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6234262PMC
December 2018

Increased risk of all-cause mortality associated with domperidone use in Parkinson's patients: a population-based cohort study in the UK.

Br J Clin Pharmacol 2018 11 9;84(11):2551-2561. Epub 2018 Aug 9.

Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute of Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands.

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http://dx.doi.org/10.1111/bcp.13708DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6177707PMC
November 2018

Precision medicine in diabetes and diabetic kidney disease: Regulatory considerations.

Diabetes Obes Metab 2018 10;20 Suppl 3:19-23

Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht, The Netherlands.

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http://doi.wiley.com/10.1111/dom.13453
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http://dx.doi.org/10.1111/dom.13453DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6220800PMC
October 2018

Drug Shortages From the Perspectives of Authorities and Pharmacy Practice in the Netherlands: An Observational Study.

Front Pharmacol 2018 31;9:1243. Epub 2018 Oct 31.

Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, Netherlands.

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https://www.frontiersin.org/article/10.3389/fphar.2018.01243
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http://dx.doi.org/10.3389/fphar.2018.01243DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6220069PMC
October 2018

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

Drug Discov Today 2018 07 21;23(7):1328-1333. Epub 2018 Mar 21.

Department of Clinical Pharmacy & Toxicology, Leiden University Medical Center, Leiden, The Netherlands. Electronic address:

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http://dx.doi.org/10.1016/j.drudis.2018.03.008DOI Listing
July 2018

Access to Strong Opioid Analgesics in the Context of Legal and Regulatory Barriers in Eleven Central and Eastern European Countries.

J Palliat Med 2018 07 6;21(7):963-969. Epub 2018 Apr 6.

1 Utrecht Institute for Pharmaceutical Sciences, Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht University , Utrecht, The Netherlands .

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http://dx.doi.org/10.1089/jpm.2017.0595DOI Listing
July 2018

When More Is Less: An Exploratory Study of the Precautionary Reporting Bias and Its Impact on Safety Signal Detection.

Clin Pharmacol Ther 2018 02 25;103(2):296-303. Epub 2017 Oct 25.

Utrecht Institute for Pharmaceutical Sciences (UIPS), Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht University, Utrecht, The Netherlands.

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http://dx.doi.org/10.1002/cpt.879DOI Listing
February 2018

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

Clin Pharmacol Ther 2018 Jan 6;103(1):120-127. Epub 2017 Nov 6.

Utrecht/WHO Collaborating Centre for Pharmaceutical Policy and Regulation, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands.

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http://dx.doi.org/10.1002/cpt.894DOI Listing
January 2018

Pharmacological vs. classical approaches in the design of first in man clinical drug trials.

Br J Clin Pharmacol 2017 12 6;83(12):2807-2812. Epub 2017 Oct 6.

Chair of the Central Committee on Research Involving Human Subjects, The Hague, The Netherlands.

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http://dx.doi.org/10.1111/bcp.13422DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5698576PMC
December 2017

Five-year trends in treatment changes in an adult cohort of HIV/AIDS patients in Ghana: a retrospective cohort study.

BMC Infect Dis 2017 10 2;17(1):664. Epub 2017 Oct 2.

Division of Pharmacoepidemiology & Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences (UIPS), PO Box 80082, 3508, TB, Utrecht, the Netherlands.

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http://dx.doi.org/10.1186/s12879-017-2752-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5625598PMC
October 2017

Primary endpoint discrepancies were found in one in ten clinical drug trials. Results of an inception cohort study.

J Clin Epidemiol 2017 Sep 20;89:199-208. Epub 2017 May 20.

Department of Epidemiology and Biostatistics, VU University Medical Center, P.O. Box 7057, 1007 MB Amsterdam, The Netherlands.

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http://dx.doi.org/10.1016/j.jclinepi.2017.05.012DOI Listing
September 2017

Recruitment failure and futility were the most common reasons for discontinuation of clinical drug trials. Results of a nationwide inception cohort study in the Netherlands.

J Clin Epidemiol 2017 Aug 6;88:140-147. Epub 2017 May 6.

Department of Epidemiology and Biostatistics, VU University Medical Center, P.O. Box 7057, 1007 MB Amsterdam, The Netherlands.

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http://dx.doi.org/10.1016/j.jclinepi.2017.05.001DOI Listing
August 2017

Pre-Exposure Prophylaxis for HIV Prevention: Safety Concerns.

Drug Saf 2017 04;40(4):273-283

World Health Organization Collaborating Centre for Advocacy and Training in Pharmacovigilance, Centre for Tropical Clinical Pharmacology and Therapeutics, School of Medicine and Dentistry, University of Ghana, Legon, Accra, Ghana.

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http://dx.doi.org/10.1007/s40264-017-0505-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5362649PMC
April 2017

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

Diabetes Obes Metab 2017 03 7;19(3):401-411. Epub 2017 Feb 7.

Department of Clinical Pharmacy and Toxicology, Maastricht University Medical Centre+, Maastricht, The Netherlands.

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http://dx.doi.org/10.1111/dom.12833DOI Listing
March 2017

Long-term use of dipeptidyl peptidase-4 inhibitors and risk of fracture: A retrospective population-based cohort study.

Diabetes Obes Metab 2017 03 19;19(3):421-428. Epub 2017 Jan 19.

Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute of Pharmaceutical Sciences, Utrecht, The Netherlands.

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http://dx.doi.org/10.1111/dom.12843DOI Listing
March 2017

Differences in VigiBase® reporting of aminoglycoside and capreomycin-suspected ototoxicity during tuberculosis treatment.

Pharmacoepidemiol Drug Saf 2017 01 20;26(1):1-8. Epub 2016 Nov 20.

Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands.

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http://dx.doi.org/10.1002/pds.4125DOI Listing
January 2017

Effects of over-the-counter sales restriction of antibiotics on substitution with medicines for symptoms relief of cold in Mexico and Brazil: time series analysis.

Health Policy Plan 2016 Nov 26;31(9):1291-6. Epub 2016 May 26.

Department of Global Health, Boston University School of Public Health, Boston, MA, USA Center for Health Systems Research, National Institute of Public Health, Cuernavaca, Mexico

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http://dx.doi.org/10.1093/heapol/czw066DOI Listing
November 2016

Association Between the Occurrence of Adverse Drug Events and Modification of First-Line Highly Active Antiretroviral Therapy in Ghanaian HIV Patients.

Drug Saf 2016 11;39(11):1139-1149

World Health Organization Collaborating Centre for Advocacy and Training in Pharmacovigilance, Centre for Tropical Clinical Pharmacology and Therapeutics, School of Medicine and Dentistry, University of Ghana, Legon, Ghana.

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http://dx.doi.org/10.1007/s40264-016-0460-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5045837PMC
November 2016

Relationship between Age and the Ability to Break Scored Tablets.

Front Pharmacol 2016 26;7:222. Epub 2016 Jul 26.

Department of Pharmaceutical Sciences, Faculty of Science, Utrecht UniversityUtrecht, Netherlands; SIR Institute for Pharmacy Practice and PolicyLeiden, Netherlands.

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http://dx.doi.org/10.3389/fphar.2016.00222DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4960263PMC
August 2016

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

Br J Clin Pharmacol 2016 07 22;82(1):213-26. Epub 2016 Apr 22.

Division of Pharmacoepidemiology & Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands.

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http://dx.doi.org/10.1111/bcp.12940DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4917806PMC
July 2016

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

Acta Oncol 2016 Jul 6;55(7):851-8. Epub 2016 May 6.

a Utrecht Institute for Pharmaceutical Sciences, Utrecht University , The Netherlands ;

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http://dx.doi.org/10.3109/0284186X.2016.1155736DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4975082PMC
July 2016

Risk of hypoglycaemia in users of sulphonylureas compared with metformin in relation to renal function and sulphonylurea metabolite group: population based cohort study.

BMJ 2016 Jul 13;354:i3625. Epub 2016 Jul 13.

Department of Clinical Pharmacy, Maastricht University Medical Centre, Maastricht, Netherlands Care and Public Health Research Institute (CAPHRI), Maastricht, Netherlands Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences Utrecht University, PO Box 80082, 3508 TB Utrecht, Netherlands.

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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4948031PMC
http://dx.doi.org/10.1136/bmj.i3625DOI Listing
July 2016

Antibiotic prescribing for children in primary care and adherence to treatment guidelines.

J Antimicrob Chemother 2016 06 5;71(6):1707-14. Epub 2016 Mar 5.

NIVEL, Netherlands Institute for Health Services Research, Utrecht, The Netherlands.

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http://dx.doi.org/10.1093/jac/dkw030DOI Listing
June 2016

Licensing failure in the European decentralised procedure.

Eur J Pharm Sci 2016 May 19;87:47-51. Epub 2015 Oct 19.

Division of Pharmacoepidemiology & Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, PO Box 80 082, 3508 TB Utrecht, the Netherlands; Medicines Evaluation Board, PO Box 8275, 3503 RG Utrecht, the Netherlands. Electronic address:

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http://dx.doi.org/10.1016/j.ejps.2015.10.014DOI Listing
May 2016

Outcomes of a Postexposure Prophylaxis Program at the Korle-Bu Teaching Hospital in Ghana: A Retrospective Cohort Study.

J Int Assoc Provid AIDS Care 2015 Nov-Dec;14(6):544-52. Epub 2013 Oct 25.

Centre for Tropical Clinical Pharmacology & Therapeutics, University of Ghana Medical School, Accra, Ghana.

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http://dx.doi.org/10.1177/2325957413508321DOI Listing
March 2016

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

Pharmacoepidemiol Drug Saf 2016 Mar 5;25 Suppl 1:21-8. Epub 2015 Jul 5.

Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, The Netherlands.

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http://dx.doi.org/10.1002/pds.3824DOI Listing
March 2016

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

Pharmacoepidemiol Drug Saf 2016 Mar 16;25(3):297-306. Epub 2015 Dec 16.

Utrecht Institute for Pharmaceutical Sciences (UIPS), Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht University, Utrecht, The Netherlands.

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http://dx.doi.org/10.1002/pds.3929DOI Listing
March 2016

Does Insight Affect the Efficacy of Antipsychotics in Acute Mania?: An Individual Patient Data Regression Meta-Analysis.

J Clin Psychopharmacol 2016 Feb;36(1):71-6

From the *Department of Psychiatry, Academic Medical Centre, University of Amsterdam, Amsterdam; †Medicines Evaluation Board, Utrecht; and ‡Netherlands Institute for Neuroscience, Royal Netherlands Academy of Arts and Sciences, Amsterdam, The Netherlands.

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http://dx.doi.org/10.1097/JCP.0000000000000435DOI Listing
February 2016

Extensions of indication throughout the drug product lifecycle: a quantitative analysis.

Drug Discov Today 2016 Feb 2;21(2):348-55. Epub 2015 Dec 2.

Department of Pharmacoepidemiology & Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, Utrecht, The Netherlands. Electronic address:

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http://dx.doi.org/10.1016/j.drudis.2015.11.009DOI Listing
February 2016

Remission of Type 2 Diabetes Mellitus in Patients After Different Types of Bariatric Surgery: A Population-Based Cohort Study in the United Kingdom.

JAMA Surg 2015 Dec;150(12):1126-33

Division of Pharmacoepidemiology & Clinical Pharmacology, Utrecht University, Utrecht, the Netherlands9Department of Clinical Pharmacy, University Medical Center Utrecht, Utrecht, the Netherlands.

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http://dx.doi.org/10.1001/jamasurg.2015.2398DOI Listing
December 2015

Comparative Performance of ATRIA, CHADS2, and CHA2DS2-VASc Risk Scores Predicting Stroke in Patients With Atrial Fibrillation: Results From a National Primary Care Database.

J Am Coll Cardiol 2015 Oct;66(17):1851-9

Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, the Netherlands; Department of Health eResearch, University of Manchester, Manchester, United Kingdom. Electronic address:

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http://dx.doi.org/10.1016/j.jacc.2015.08.033DOI Listing
October 2015

Reply to "decrease in penicillin sales in Brazil after over-the-counter restrictions".

Antimicrob Agents Chemother 2015 Sep;59(9):5864

Department of Global Health, Boston University School of Public Health, Boston, Massachusetts, USA Center for Health Systems Research, National Institute of Public Health, Cuernavaca, Mexico

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http://dx.doi.org/10.1128/AAC.01128-15DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4538527PMC
September 2015

Bone fracture risk is not associated with the use of glucagon-like peptide-1 receptor agonists: a population-based cohort analysis.

Calcif Tissue Int 2015 Aug 17;97(2):104-12. Epub 2015 Apr 17.

Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute of Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands.

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http://dx.doi.org/10.1007/s00223-015-9993-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4491344PMC
August 2015

Selection of essential medicines for diabetes in low and middle income countries: a survey of 32 national essential medicines lists.

PLoS One 2014 26;9(9):e106072. Epub 2014 Sep 26.

Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, the Netherlands.

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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0106072PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4178014PMC
June 2015

Adverse events and adherence to HIV post-exposure prophylaxis: a cohort study at the Korle-Bu Teaching Hospital in Accra, Ghana.

BMC Public Health 2015 Jun 20;15:573. Epub 2015 Jun 20.

World Health Organisation Collaborating Centre for Advocacy and Training in Pharmacovigilance, Centre for Tropical Clinical Pharmacology & Therapeutics, School of Medicine and Dentistry, University of Ghana, P. O. Box GP 4236, Accra, Ghana.

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http://dx.doi.org/10.1186/s12889-015-1928-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4474444PMC
June 2015

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

Diabetes Care 2015 Mar 31;38(3):495-502. Epub 2014 Dec 31.

Utrecht Institute of Pharmaceutical Sciences, Utrecht University, Utrecht, the Netherlands

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http://care.diabetesjournals.org/content/38/3/495.full.pdf
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http://care.diabetesjournals.org/lookup/doi/10.2337/dc14-117
Publisher Site
http://dx.doi.org/10.2337/dc14-1175DOI Listing
March 2015

Essential medicines are more available than other medicines around the globe.

PLoS One 2014 12;9(2):e87576. Epub 2014 Feb 12.

Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, the Netherlands.

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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0087576PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3922716PMC
January 2015

Seasonal variation in penicillin use in Mexico and Brazil: analysis of the impact of over-the-counter restrictions.

Antimicrob Agents Chemother 2015 Jan 13;59(1):105-10. Epub 2014 Oct 13.

Center for Global Health and Development, Boston University, Boston, Massachusetts, USA Center for Health Systems Research, National Institute of Public Health, Cuernavaca, Mexico

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http://dx.doi.org/10.1128/AAC.03629-14DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4291337PMC
January 2015

Traceability of biologicals: present challenges in pharmacovigilance.

Expert Opin Drug Saf 2015 Jan 5;14(1):63-72. Epub 2014 Nov 5.

Utrecht University, Utrecht Institute for Pharmaceutical Sciences (UIPS), Division of Pharmacoepidemiology and Clinical Pharmacology , Universiteitsweg 99, Utrecht, 3584CG , The Netherlands +31 302537324 ; +31 302539166 ;

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http://dx.doi.org/10.1517/14740338.2015.972362DOI Listing
January 2015

Essential medicines for COPD and asthma in low and middle-income countries.

Thorax 2014 Dec 3;69(12):1149-51. Epub 2014 Mar 3.

Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands.

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http://dx.doi.org/10.1136/thoraxjnl-2014-205249DOI Listing
December 2014

Risk of fracture in patients with Charcot-Marie-Tooth disease.

Muscle Nerve 2014 Dec;50(6):919-24

Utrecht Institute for Pharmaceutical Sciences, University of Utrecht, Universiteitsweg 99, 3584, CG Utrecht, The Netherlands.

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http://dx.doi.org/10.1002/mus.24240DOI Listing
December 2014

Regulatory watch: Outcomes of EMA marketing authorization applications: does partnering have an influence?

Nat Rev Drug Discov 2014 Dec 14;13(12):878. Epub 2014 Nov 14.

Central Committee on Research Involving Human Subjects, P.O. Box 16302, 2500 BH The Hague, The Netherlands.

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http://dx.doi.org/10.1038/nrd4468DOI Listing
December 2014

Practical problems with medication use that older people experience: a qualitative study.

J Am Geriatr Soc 2014 Dec;62(12):2339-44

Department of Public Health Effects, National Institute for Public Health and the Environment, Bilthoven, The Netherlands.

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http://dx.doi.org/10.1111/jgs.13126DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4293156PMC
December 2014

Use of dipeptidyl peptidase-4 inhibitors for type 2 diabetes mellitus and risk of fracture.

Bone 2014 Nov 2;68:124-30. Epub 2014 Aug 2.

Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute of Pharmaceutical Sciences, Utrecht, The Netherlands; Care and Public Health Research Institute (CAPHRI), Maastricht, The Netherlands; Department of Clinical Pharmacy and Toxicology, Maastricht University Medical Centre+, Maastricht, The Netherlands; MRC Epidemiology Lifecourse Unit, Southampton General Hospital, Southampton UK. Electronic address:

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http://dx.doi.org/10.1016/j.bone.2014.07.030DOI Listing
November 2014

Regulatory decision-making: are we getting it right?

Pharmacoepidemiol Drug Saf 2014 Oct 11;23(10):1012-6. Epub 2014 Aug 11.

Department of Medical Statistics, The London School of Hygiene and Tropical Medicine, London, UK.

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http://dx.doi.org/10.1002/pds.3695DOI Listing
October 2014

Sources of heterogeneity in case-control studies on associations between statins, ACE-inhibitors, and proton pump inhibitors and risk of pneumonia.

Eur J Epidemiol 2014 Oct 26;29(10):767-75. Epub 2014 Aug 26.

Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Faculty of Science, Utrecht University, PO Box 80082, 3508 TB, Utrecht, The Netherlands,

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http://dx.doi.org/10.1007/s10654-014-9941-0DOI Listing
October 2014

Participation of older people in preauthorization trials of recently approved medicines.

J Am Geriatr Soc 2014 Oct 3;62(10):1883-90. Epub 2014 Oct 3.

Department of Geriatric Medicine, University Medical Center, Utrecht, The Netherlands; Expertise Centre Pharmacotherapy in Old Persons, University Medical Center, Utrecht, The Netherlands.

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http://dx.doi.org/10.1111/jgs.13067DOI Listing
October 2014

Mortality in British hip fracture patients, 2000-2010: a population-based retrospective cohort study.

Bone 2014 Sep 14;66:171-7. Epub 2014 Jun 14.

Utrecht Institute for Pharmaceutical Sciences, Utrecht University, 3584 CG Utrecht, Netherlands; MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton General Hospital, Southampton SO16 6YD, United Kingdom; Maastricht University Medical Center, Department of Clinical Pharmacy and Toxicology, 6202 AZ Maastricht, Netherlands; Maastricht University/CAPHRI, 6200 MD Maastricht, Netherlands. Electronic address:

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http://dx.doi.org/10.1016/j.bone.2014.06.011DOI Listing
September 2014

Effect of the economic recession on pharmaceutical policy and medicine sales in eight European countries.

Bull World Health Organ 2014 Sep 16;92(9):630-640D. Epub 2014 Jun 16.

Department of Essential Medicines and Pharmaceutical Policies, World Health Organization, Geneva, Switzerland .

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http://dx.doi.org/10.2471/BLT.13.129114DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4208566PMC
September 2014

Impact of over-the-counter restrictions on antibiotic consumption in Brazil and Mexico.

PLoS One 2013 16;8(10):e75550. Epub 2013 Oct 16.

WHO Collaborating Centre for Pharmaceutical Policy & Regulation, Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht, The Netherlands.

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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0075550PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3797702PMC
July 2014

The views of healthcare professionals, drug developers and regulators on information about older people needed for rational drug prescription.

PLoS One 2013 16;8(8):e72060. Epub 2013 Aug 16.

Department of Geriatric Medicine and Expertise Centre Pharmacotherapy in Old Persons (EPHOR), University Medical Center Utrecht, Utrecht, The Netherlands.

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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0072060PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3745417PMC
April 2014

β-Adrenoceptor blockers and pulmonary function in the general population: the Rotterdam Study.

Br J Clin Pharmacol 2014 Jan;77(1):190-200

Department of Epidemiology, Erasmus Medical Center, Rotterdam, The Netherlands; Inspectorate of Health Care, The Hague, The Netherlands.

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http://dx.doi.org/10.1111/bcp.12181DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3895360PMC
January 2014

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

Curr Drug Saf 2013 Nov;8(5):371-8

Division of Pharmacoepidemiology and Pharmacotherapy, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, The Netherlands.

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http://dx.doi.org/10.2174/15748863113086660070DOI Listing
November 2013

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

Curr Drug Saf 2013 Nov;8(5):364-70

Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, PO-box 80082, 3508 TB Utrecht, The Netherlands.

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http://dx.doi.org/10.2174/15748863113086660069DOI Listing
November 2013

Use of metformin and survival of diabetic women with breast cancer.

Curr Drug Saf 2013 Nov;8(5):357-63

Department of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute of Pharmaceutical Sciences, Utrecht University, Universiteitsweg 99, 3584 CG Utrecht, The Netherlands.

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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5421139PMC
http://dx.doi.org/10.2174/15680266113136660069DOI Listing
November 2013

Drug development for exceptionally rare metabolic diseases: challenging but not impossible.

Orphanet J Rare Dis 2013 Nov 15;8:179. Epub 2013 Nov 15.

Utrecht Institute for Pharmaceutical Sciences, Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht University, P,O, Box 80 082, 3508TB Utrecht, The Netherlands.

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http://dx.doi.org/10.1186/1750-1172-8-179DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3843583PMC
November 2013

Is Europe still heading to a common price level for on-patent medicines? An exploratory study among 15 Western European countries.

Health Policy 2013 Oct 8;112(3):209-16. Epub 2013 Sep 8.

Department of Health Economics, Gesundheit Österreich GmbH/Austrian Health Institute/WHO Collaborating Centre for Pricing and Reimbursement Policies, Vienna, Austria; Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences/WHO Collaborating Centre for Pharmaceutical Policy and Regulation, Utrecht, The Netherlands. Electronic address:

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http://dx.doi.org/10.1016/j.healthpol.2013.08.012DOI Listing
October 2013

Measures of biosimilarity in monoclonal antibodies in oncology: the case of bevacizumab.

Drug Discov Today 2013 Sep 18;18(17-18):872-9. Epub 2013 May 18.

Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands.

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http://dx.doi.org/10.1016/j.drudis.2013.05.004DOI Listing
September 2013

Appropriate evidence for adaptive marketing authorization.

Nat Rev Drug Discov 2013 Sep;12(9):647-8

The Escher Project, David de Wiedgebouw, Universiteitsweg 99, 3584CG, Utrecht, and Exon Consultancy, The Netherlands.

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http://dx.doi.org/10.1038/nrd4114DOI Listing
September 2013

Traceability of biopharmaceuticals in spontaneous reporting systems: a cross-sectional study in the FDA Adverse Event Reporting System (FAERS) and EudraVigilance databases.

Drug Saf 2013 Aug;36(8):617-25

Utrecht Institute for Pharmaceutical Sciences (UIPS), Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht University, Universiteitsweg 99, 3584CG, Utrecht, The Netherlands.

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http://dx.doi.org/10.1007/s40264-013-0073-3DOI Listing
August 2013

Future of the European Union regulatory network in the context of the uptake of new medicines.

Br J Clin Pharmacol 2013 Jul;76(1):1-6

Utrecht Institute for Pharmaceutical Sciences, Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht University, Utrecht, the Netherlands.

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http://dx.doi.org/10.1111/j.1365-2125.2012.04476.xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3703222PMC
July 2013

Statins, systemic inflammation and risk of death in COPD: the Rotterdam study.

Pulm Pharmacol Ther 2013 Apr 7;26(2):212-7. Epub 2012 Nov 7.

Department of Respiratory Medicine, Ghent University Hospital, De Pintelaan 185, 9000 Ghent, Belgium.

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http://dx.doi.org/10.1016/j.pupt.2012.10.008DOI Listing
April 2013

Increased use of antimicrobial agents and hospital admission for infections in patients with primary adrenal insufficiency: a cohort study.

Eur J Endocrinol 2013 Apr 15;168(4):609-14. Epub 2013 Mar 15.

Department of Internal Medicine and Infectious Diseases (Section Endocrinology), Utrecht University Medical Center, Utrecht, The Netherlands.

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http://dx.doi.org/10.1530/EJE-12-0879DOI Listing
April 2013

Differences between post-authorization adverse drug reactions of biopharmaceuticals and small molecules.

BioDrugs 2013 Apr;27(2):167-74

Division of Pharmacoepidemiology and Clinical Pharmacology, Faculty of Science, Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, P.O. Box 80 082, 3508 TB Utrecht, The Netherlands.

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http://dx.doi.org/10.1007/s40259-013-0012-yDOI Listing
April 2013

Information for adequate prescribing to older patients : an evaluation of the product information of 53 recently approved medicines.

Drugs Aging 2013 Apr;30(4):255-62

Department of Geriatric Medicine and Expertise Centre Pharmacotherapy in Old Persons (EPHOR), University Medical Center, Huispost B05.256, P.O. Box 85500, 3508 GA, Utrecht, The Netherlands.

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http://dx.doi.org/10.1007/s40266-013-0059-yDOI Listing
April 2013

Risk of fracture with thiazolidinediones: an individual patient data meta-analysis.

Front Endocrinol (Lausanne) 2013 26;4:11. Epub 2013 Feb 26.

Utrecht Institute for Pharmaceutical Sciences, Utrecht University Utrecht, Netherlands.

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http://dx.doi.org/10.3389/fendo.2013.00011DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3582108PMC
April 2013

The role of Periodic Safety Update Reports in the safety management of biopharmaceuticals.

Eur J Clin Pharmacol 2013 Feb 17;69(2):217-26. Epub 2012 Jun 17.

Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences (UIPS), Faculty of Science, Utrecht University, P.O. Box 80 082, 3508 TB, Utrecht, The Netherlands.

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http://dx.doi.org/10.1007/s00228-012-1317-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3548093PMC
February 2013

COX-2-selective NSAIDs and risk of hip or knee replacements: a population-based case-control study.

Calcif Tissue Int 2012 Dec 9;91(6):387-94. Epub 2012 Oct 9.

Division of Pharmacoepidemiology & Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Universiteitsweg 99, 3584 CG, Utrecht, The Netherlands.

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http://dx.doi.org/10.1007/s00223-012-9646-xDOI Listing
December 2012

Reasons for and time to discontinuation of rimonabant therapy: a modified prescription-event monitoring study.

Drug Saf 2012 Dec;35(12):1147-58

Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, the Netherlands.

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http://dx.doi.org/10.1007/bf03262000DOI Listing
December 2012

Switching from originator brand medicines to generic equivalents in selected developing countries: how much could be saved?

Value Health 2012 Jul-Aug;15(5):664-73. Epub 2012 Jul 11.

Essential Medicines and Pharmaceutical Policies, World Health Organization, Geneva, Switzerland.

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http://dx.doi.org/10.1016/j.jval.2012.04.004DOI Listing
October 2012

Rituximab-induced thrombocytopenia: a cohort study.

Eur J Haematol 2012 Sep 5;89(3):256-66. Epub 2012 Jul 5.

Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands.

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http://dx.doi.org/10.1111/j.1600-0609.2012.01808.xDOI Listing
September 2012

A cohort study exploring determinants of safety-related regulatory actions for biopharmaceuticals.

Drug Saf 2012 May;35(5):417-27

Utrecht Institute for Pharmaceutical Sciences-UIPS, Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht University, Utrecht, the Netherlands.

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http://dx.doi.org/10.2165/11597850-000000000-00000DOI Listing
May 2012