Literature DB >> 23989775

Appropriate evidence for adaptive marketing authorization.

Jean Philippe de Jong1, Diederick E Grobbee, Bruno Flamion, Susan R Forda, Hubert G M Leufkens.   

Abstract

Mesh:

Year:  2013        PMID: 23989775     DOI: 10.1038/nrd4114

Source DB:  PubMed          Journal:  Nat Rev Drug Discov        ISSN: 1474-1776            Impact factor:   84.694


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  4 in total

1.  Multicriteria benefit-risk assessment using network meta-analysis.

Authors:  Gert van Valkenhoef; Tommi Tervonen; Jing Zhao; Bert de Brock; Hans L Hillege; Douwe Postmus
Journal:  J Clin Epidemiol       Date:  2011-12-23       Impact factor: 6.437

2.  The cost-effectiveness of drug regulation: the example of thorough QT/QTc studies.

Authors:  J C Bouvy; M A Koopmanschap; R R Shah; H Schellekens
Journal:  Clin Pharmacol Ther       Date:  2011-12-28       Impact factor: 6.875

Review 3.  Adaptive licensing: taking the next step in the evolution of drug approval.

Authors:  H-G Eichler; K Oye; L G Baird; E Abadie; J Brown; C L Drum; J Ferguson; S Garner; P Honig; M Hukkelhoven; J C W Lim; R Lim; M M Lumpkin; G Neil; B O'Rourke; E Pezalla; D Shoda; V Seyfert-Margolis; E V Sigal; J Sobotka; D Tan; T F Unger; G Hirsch
Journal:  Clin Pharmacol Ther       Date:  2012-02-15       Impact factor: 6.875

4.  Regulatory scientific advice in drug development: does company size make a difference?

Authors:  Michelle Putzeist; Aukje K Mantel-Teeuwisse; Christine C Gispen-De Wied; Arno W Hoes; Hubert G Leufkens
Journal:  Eur J Clin Pharmacol       Date:  2010-11-04       Impact factor: 2.953

  4 in total
  2 in total

1.  The implementation of novel collaborative structures for the identification and resolution of barriers to pluripotent stem cell translation.

Authors:  David A Brindley; Anna French; Jane Suh; MacKenna Roberts; Benjamin Davies; Rafael Pinedo-Villanueva; Karolina Wartolowska; Kelly Rooke; Anneke Kramm; Andrew Judge; Mark Morrey; Amit Chandra; Hannah Hurley; Liam Grover; Ian Bingham; Bernard Siegel; Matt S Rattley; R Lee Buckler; David McKeon; Katie Krumholz; Lilian Hook; Michael May; Sarah Rikabi; Rosie Pigott; Megan Morys; Afsie Sabokbar; Emily Titus; Yacine Laabi; Gilles Lemaitre; Raymond Zahkia; Doug Sipp; Robert Horne; Christopher Bravery; David Williams; Ivan Wall; Evan Y Snyder; Jeffrey M Karp; Richard W Barker; Kim Bure; Andrew J Carr; Brock Reeve
Journal:  Stem Cells Dev       Date:  2013-12       Impact factor: 3.272

Review 2.  European perspective for effective cancer drug development.

Authors:  Denis Lacombe; Sabine Tejpar; Roberto Salgado; Fatima Cardoso; Vassilis Golfinopoulos; Daniela Aust; Gunnar Folprecht; Arnaud Roth; Roger Stupp
Journal:  Nat Rev Clin Oncol       Date:  2014-06-17       Impact factor: 66.675

  2 in total

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