Literature DB >> 29977052

The evolution of adaptiveness: balancing speed and evidence.

Hans-Georg Eichler1, Richard Barker2, Nicola Bedlington3, Jacoline C Bouvy4, André W Broekmans5, Anna Bucsics6, Francesca Cerreta1, Solange Corriol-Rohou7, Alicia Granados8, Yann Le Cam9, Ad Schuurman10.   

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Year:  2018        PMID： 29977052     DOI： 10.1038/nrd.2018.90

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


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  3 in total

Review 1.  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

Review 2.  Larger effect sizes in nonrandomized studies are associated with higher rates of EMA licensing approval.

Authors:  Benjamin Djulbegovic; Paul Glasziou; Farina A Klocksieben; Tea Reljic; Magali VanDenBergh; Rahul Mhaskar; John P A Ioannidis; Iain Chalmers
Journal:  J Clin Epidemiol       Date:  2018-02-10       Impact factor: 6.437

3.  Managed Entry Agreements for Pharmaceuticals in the Context of Adaptive Pathways in Europe.

Authors:  Jacoline C Bouvy; Claudine Sapede; Sarah Garner
Journal:  Front Pharmacol       Date:  2018-03-27       Impact factor: 5.810
  3 in total
  1 in total

Review 1.  The ENCePP Code of Conduct: A best practise for scientific independence and transparency in noninterventional postauthorisation studies.

Authors:  Rosa Gini; Xavier Fournie; Helen Dolk; Xavier Kurz; Patrice Verpillat; François Simondon; Valerie Strassmann; Kathi Apostolidis; Thomas Goedecke
Journal:  Pharmacoepidemiol Drug Saf       Date:  2019-03-05       Impact factor: 2.890
  1 in total

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