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4 research outputs found
Design and analysis of non-inferiority mortality trials in oncology
Author
Committee for Propriety Medicinal Products
Fisher
+6Â more
Hung
ICH Topic E10
ICH Topic E9
Rothmann
Shlaes
Wang
Publication venue
'Wiley'
Publication date
01/01/2004
Field of study
No full text
Crossref
Therapeutic equivalence: fallacies and falsification
Author
Bristol
Choi
+38Â more
Cox
CPMP
CPMP
CPMP
CPMP
CPMP
CPMP
CPMP note for guidance (III/3630/92-EN)
Dunnett
Ebbutt
FDA
FDA
FDA
Ford
Gail
Goldberg
Hsieh
Hutton
ICH topic E10
ICH topic E9
Lee
Lewis
Little
Makuch
Morikawa
Nelder
Phillips
Robinson
Robinson
Röhmel
Röhmel
SAS Institute Inc.
SAS Institute Inc.
Senn
Senn
Senn
Tu
Whitehead
Publication venue
'Wiley'
Publication date
01/01/2003
Field of study
No full text
Crossref
Active-controlled, non-inferiority trials in oncology: arbitrary limits, infeasible sample sizes and uninformative data analysis. Is there another way?
Author
Carroll
Committee for Medicinal Products for Human use (CHMP)
+22Â more
FDA/CDER New and Generic Drug Approvals: 1998–2004
FDA/CDER New and Generic Drug Approvals: Taxotare (docetaxol for injection concentrate) statistical review
FDA/CDER New and Generic Drug Approvals: Xeloda (capecitabine tablets) product labelling
Fisher
Hanna
Hung
Hung
ICH Topic E10
ICH Topic E9
Jones
Rothmann
Rothmann
Schoenfeld
Senn
Shepherd
Shlaes
Simon
Snapinn
US Food and Drug Administration Division of Oncologic Drug Products Advisory Committee meeting transcript
Wang
Wang
Wang
Publication venue
'Wiley'
Publication date
01/01/2006
Field of study
No full text
Crossref
Comparators (Medicinal and non Medicinal) for Marketing Authorization, for Public Health, for Payers and at the European Level
Author
Alain Francillon
Alain Joseph
+40Â more
Alexandre Barna
Andersson
Anne d’Andon
Atkins
Berwick
Catherine Lassale
Chalkidou
Chalmers
Clement
Corine Bernaud
Danièle Girault
Dawson
Driss BerdaĂŻ
Elisabeth Frauger
EMEA/CPMP position statement on the use of placebo in clinical trials with regard to the revised declaration of Helsinki
Eric Vicaut
EU standard of medicinal product registration: clinical evaluation of risk/benefit - The role of comparator studies
Florence Mahlberg-Gaudin
Garattini
Glickman
ICH topic E10
Isabelle Boucot
Isabelle Cheiney
Jean-François Bergman
Jean-Marc Harlin
Jean-Michel Hotton
Jérôme d’Enfert
Laurent Becquemont
Lise Rochaix
Luce
Marley
Michel Cucherat
Mira Pavlovic
Mitka
Philippe Lechat
Rawlins
Sophie Ravoire
Table Ronde n°2 de Giens XXIII
Thierry Moreau-Defarges
Van Luijn
Publication venue
'EDP Sciences'
Publication date
Field of study
No full text
Crossref