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Safety studies

On the coherence of model-based dose-finding designs for drug combination trials

Yeonhee Park, Suyu Liu

Efficacy, tolerability, and safety of an innovative medical device for improving oral accessibility during oral examination in special-needs patients: A multicentric clinical trial

Mathieu Mogenot, Laurence Hein-Halbgewachs, [ ... ], Daniel Anastasio

Institutional work to maintain, repair, and improve the regulatory regime: How actors respond to external challenges in the public supervision of ongoing clinical trials in the Netherlands

Jacqueline C. F. van Oijen, Iris Wallenburg, Roland Bal, Kor J. Grit

Lower-dose prescriptions in the post-marketing situation and the influencing factors thereon

Akiko Ogata, Masayuki Kaneko, Mamoru Narukawa

Safety and efficacy of glecaprevir/pibrentasvir for the treatment of chronic hepatitis C in patients aged 65 years or older

Graham R. Foster, Tarik Asselah, [ ... ], Federico J. Mensa

Central adjudication of serious adverse events did not affect trial’s safety results: Data from the Efficacy of Nitric Oxide in Stroke (ENOS) trial

Peter J. Godolphin, Alan A. Montgomery, [ ... ], on behalf of the ENOS Investigators

The role of the State Security Service (Stasi) in the context of international clinical trials conducted by western pharmaceutical companies in Eastern Germany (1961–1990)

Rainer Erices, Andreas Frewer, Antje Gumz

The real-world effectiveness and safety of fingolimod in relapsing-remitting multiple sclerosis patients: An observational study

Guillermo Izquierdo, Fátima Damas, [ ... ], Guillermo Navarro

Safety and Efficacy of Methotrexate in Psoriasis: A Meta-Analysis of Published Trials

Jonathan West, Simon Ogston, John Foerster

Epoch Analysis of On-Treatment Disability Progression Events over Time in the Tysabri Observational Program (TOP)

Heinz Wiendl, Helmut Butzkueven, [ ... ], Tysabri ® Observational Program (TOP) Investigators

Premarket Safety and Efficacy Studies for ADHD Medications in Children

Florence T. Bourgeois, Jeong Min Kim, Kenneth D. Mandl

Paediatric Pharmacovigilance: Use of Pharmacovigilance Data Mining Algorithms for Signal Detection in a Safety Dataset of a Paediatric Clinical Study Conducted in Seven African Countries

Dan K. Kajungu, Annette Erhart, [ ... ], Niko Speybroeck

Women Versus Men with Chronic Atrial Fibrillation: Insights from the Standard Versus Atrial Fibrillation spEcific managemenT studY (SAFETY)

Jocasta Ball, Melinda J. Carrington, [ ... ], the SAFETY Investigators

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