Regulatory Scientific Advice on Non-Inferiority Drug Trials

Grace Wangge; Michelle Putzeist; Mirjam J. Knol; Olaf H. Klungel; Christine C. Gispen-De Wied; Antonius de Boer; Arno W. Hoes; Hubert G. Leufkens; Aukje K. Mantel-Teeuwisse

doi:10.1371/journal.pone.0074818

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Open Access

Peer-reviewed

Research Article

Regulatory Scientific Advice on Non-Inferiority Drug Trials

Grace Wangge ,

Contributed equally to this work with: Grace Wangge, Michelle Putzeist

Affiliations Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, Utrecht, The Netherlands, Medicines Evaluation Board, Utrecht, The Netherlands
⨯
Michelle Putzeist ,

Contributed equally to this work with: Grace Wangge, Michelle Putzeist

Affiliations Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, Utrecht, The Netherlands, Medicines Evaluation Board, Utrecht, The Netherlands
⨯
Mirjam J. Knol,

Affiliation Rijksinstituut voor Volksgezondheid en Milieu (RIVM), National Institute for Public Health and the Environment, Centre for Infectious Disease Control Netherlands (CIb), Epidemiology and Surveillance Unit (EPI), Bilthoven, The Netherlands
⨯
Olaf H. Klungel,

Affiliation Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, Utrecht, The Netherlands
⨯
Christine C. Gispen-De Wied,

Affiliation Medicines Evaluation Board, Utrecht, The Netherlands
⨯
Antonius de Boer,

Affiliation Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, Utrecht, The Netherlands
⨯
Arno W. Hoes,

Affiliation Julius Centre for Health Sciences and Primary Care, University Medical Centre Utrecht, Utrecht, The Netherlands
⨯
Hubert G. Leufkens,

Affiliations Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, Utrecht, The Netherlands, Medicines Evaluation Board, Utrecht, The Netherlands
⨯
Aukje K. Mantel-Teeuwisse

* E-mail: A.K.Mantel@uu.nl

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

Regulatory Scientific Advice on Non-Inferiority Drug Trials

Grace Wangge,
Michelle Putzeist,
Mirjam J. Knol,
Olaf H. Klungel,
Christine C. Gispen-De Wied,
Antonius de Boer,
Arno W. Hoes,
Hubert G. Leufkens,
Aukje K. Mantel-Teeuwisse

Published: September 5, 2013
https://doi.org/10.1371/journal.pone.0074818

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