Literature DB >> 25524018

European regulatory experience with drugs for central nervous system disorders.

Florence Butlen-Ducuing1, Malgorzata Zienowicz1, Frank Pétavy1, Manuel Haas1, Tomas Salmonson2, Hans-Georg Eichler1, Guido Rasi1.   

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Year:  2014        PMID： 25524018     DOI： 10.1038/nrd4511

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


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  3 in total

1.  Access to patient-level trial data--a boon to drug developers.

Authors:  Hans-Georg Eichler; Frank Pétavy; Francesco Pignatti; Guido Rasi
Journal:  N Engl J Med       Date:  2013-10-21       Impact factor: 91.245

2.  Factors associated with success of market authorisation applications for pharmaceutical drugs submitted to the European Medicines Agency.

Authors:  Jan Regnstrom; Franz Koenig; Bo Aronsson; Tatiana Reimer; Kristian Svendsen; Stelios Tsigkos; Bruno Flamion; Hans-Georg Eichler; Spiros Vamvakas
Journal:  Eur J Clin Pharmacol       Date:  2009-11-20       Impact factor: 2.953

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
  3 in total

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