Hubertus M. Leufkens

Utrecht, UT, Netherlands

Last Updated: 09/26/2026

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Found 16 publications

Through the lens of marketing authorization holders: experience in use of real-world data and real-world evidence in drug development and regulatory submissions in EU.

Through the lens of marketing authorization holders: experience in use of real-world data and real-world evidence in drug development and regulatory submissions in EU.

Journal: British journal of clinical pharmacology

Published: September 21, 2025

The role of Real-World Data and evidence in oncology medicines approved in EU in 2018-2019.

The role of Real-World Data and evidence in oncology medicines approved in EU in 2018-2019.

Journal: Journal of cancer policy

Published: February 10, 2023

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

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

Journal: Clinical pharmacology and therapeutics

Published: July 14, 2021

Use of Opioids Increases With Age in Older Adults: An Observational Study (2005-2017).

Use of Opioids Increases With Age in Older Adults: An Observational Study (2005-2017).

Journal: Frontiers in pharmacology

Published: September 13, 2019

Dose-Finding Studies Among Orphan Drugs Approved in the EU: A Retrospective Analysis.

Dose-Finding Studies Among Orphan Drugs Approved in the EU: A Retrospective Analysis.

Journal: Journal of clinical pharmacology

Published: May 07, 2018

The impact of second generation antipsychotics on insight in schizophrenia: Results from 14 randomized, placebo controlled trials.

The impact of second generation antipsychotics on insight in schizophrenia: Results from 14 randomized, placebo controlled trials.

Journal: European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology

Published: April 12, 2016

Occurrence and determinants of selective reporting of clinical drug trials: design of an inception cohort study.

Occurrence and determinants of selective reporting of clinical drug trials: design of an inception cohort study.

Journal: BMJ open

Published: July 09, 2015

Statins and Risk of Lower Limb Revision Surgery: The Influence of Differences in Study Design Using Electronic Health Records From the United Kingdom and Denmark.

Statins and Risk of Lower Limb Revision Surgery: The Influence of Differences in Study Design Using Electronic Health Records From the United Kingdom and Denmark.

Journal: American journal of epidemiology

Published: May 22, 2015

Impact of DSM-5 changes on the diagnosis and acute treatment of schizophrenia.

Impact of DSM-5 changes on the diagnosis and acute treatment of schizophrenia.

Journal: Schizophrenia bulletin

Published: December 22, 2014

Geographic variation in efficacy of atypical antipsychotics for the acute treatment of schizophrenia - an individual patient data meta-analysis.

Geographic variation in efficacy of atypical antipsychotics for the acute treatment of schizophrenia - an individual patient data meta-analysis.

Journal: European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology

Published: November 22, 2013

From molecule to market access: drug regulatory science as an upcoming discipline.

From molecule to market access: drug regulatory science as an upcoming discipline.

Journal: European journal of pharmacology

Published: April 24, 2013

Changes in mortality patterns following total hip or knee arthroplasty over the past two decades: a nationwide cohort study.

Changes in mortality patterns following total hip or knee arthroplasty over the past two decades: a nationwide cohort study.

Journal: Arthritis & rheumatology (Hoboken, N.J.)

Published: February 15, 2013

Showing 1-12 of 16

Last Updated: 09/26/2026