Literature DB >> 20354022

Europe's opportunity to open up drug regulation.

Silvio Garattini1, Vittorio Bertele'.   

Abstract

Mesh：

Year:  2010        PMID： 20354022     DOI： 10.1136/bmj.c1578

Source DB:  PubMed          Journal:  BMJ        ISSN： 0959-8138


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  3 in total

1.  A cohort study exploring determinants of safety-related regulatory actions for biopharmaceuticals.

Authors:  Hans C Ebbers; Aukje K Mantel-Teeuwisse; Ellen H M Moors; Fakhredin A Sayed Tabatabaei; Huub Schellekens; Hubert G M Leufkens
Journal:  Drug Saf       Date:  2012-05-01       Impact factor: 5.606

2.  Risk Management Plans: are they a tool for improving drug safety?

Authors:  Serena Frau; Maria Font Pous; Maria Rosa Luppino; Anita Conforti
Journal:  Eur J Clin Pharmacol       Date:  2010-06-25       Impact factor: 2.953

3.  Disclosure of grounds of European withdrawn and refused applications: a step forward on regulatory transparency.

Authors:  Giovanni Tafuri; Francesco Trotta; Hubert G M Leufkens; Luca Pani
Journal:  Br J Clin Pharmacol       Date:  2013-04       Impact factor: 4.335
  3 in total

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