Literature DB >> 22743964

New horizons in pharmaceutical regulation.

Alasdair Breckenridge1, Michelle Mello, Bruce M Psaty.   

Abstract

A life cycle approach to pharmaceutical regulation, in which the benefit-risk balance of new drugs continues to be robustly assessed following market approval, is emerging in both the United States and Europe.

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Year:  2012        PMID: 22743964     DOI: 10.1038/nrd3787

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


  1 in total

1.  Safe drugs and the cost of good intentions.

Authors:  Hans-Georg Eichler; Eric Abadie; June M Raine; Tomas Salmonson
Journal:  N Engl J Med       Date:  2009-04-02       Impact factor: 91.245

  1 in total
  3 in total

1.  Towards a prevention model of health care.

Authors:  Alasdair Breckenridge; Hans-Georg Eichler
Journal:  Nat Rev Drug Discov       Date:  2013-08       Impact factor: 84.694

2.  Priorities for improving drug research, development and regulation.

Authors:  Susan R Forda; Richard Bergström; Magda Chlebus; Richard Barker; Peter Høngaard Andersen
Journal:  Nat Rev Drug Discov       Date:  2013-04       Impact factor: 84.694

3.  Characteristics and follow-up of postmarketing studies of conditionally authorized medicines in the EU.

Authors:  Jarno Hoekman; Thea T Klamer; Aukje K Mantel-Teeuwisse; Hubert G M Leufkens; Marie L De Bruin
Journal:  Br J Clin Pharmacol       Date:  2016-04-22       Impact factor: 4.335

  3 in total

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