Literature DB >> 22242707

Minimum quality criteria are needed in the assessment and communication of unexpected drug safety findings of marketed products from randomized controlled trials.

Robert Hermann, Peter Cnota, Joachim Maus.   

Abstract

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Year:  2012        PMID： 22242707      PMCID： PMC3394148          DOI： 10.1111/j.1365-2125.2012.04176.x

Source DB:  PubMed          Journal:  Br J Clin Pharmacol        ISSN： 0306-5251            Impact factor:   4.335


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  7 in total

1.  Unexpected frequent hepatotoxicity of a prescription drug, flupirtine, marketed for about 30 years.

Authors:  Martin C Michel; Piotr Radziszewski; Christian Falconer; Daniela Marschall-Kehrel; Koenraad Blot
Journal:  Br J Clin Pharmacol       Date:  2012-05       Impact factor: 4.335

2.  Approaches to the study of drug-induced liver injury.

Authors:  R J Fontana
Journal:  Clin Pharmacol Ther       Date:  2010-07-21       Impact factor: 6.875

3.  Improving the quality of reporting of randomized controlled trials. The CONSORT statement.

Authors:  C Begg; M Cho; S Eastwood; R Horton; D Moher; I Olkin; R Pitkin; D Rennie; K F Schulz; D Simel; D F Stroup
Journal:  JAMA       Date:  1996-08-28       Impact factor: 56.272

Review 4.  Drug-induced liver injury.

Authors:  Gebran Abboud; Neil Kaplowitz
Journal:  Drug Saf       Date:  2007       Impact factor: 5.606

Review 5.  Case definition and phenotype standardization in drug-induced liver injury.

Authors:  G P Aithal; P B Watkins; R J Andrade; D Larrey; M Molokhia; H Takikawa; C M Hunt; R A Wilke; M Avigan; N Kaplowitz; E Bjornsson; A K Daly
Journal:  Clin Pharmacol Ther       Date:  2011-05-04       Impact factor: 6.875

Review 6.  Causality assessment in hepatotoxicity by drugs and dietary supplements.

Authors:  Rolf Teschke; Alexander Schwarzenboeck; Karl-Heinz Hennermann
Journal:  Br J Clin Pharmacol       Date:  2008-12       Impact factor: 4.335

7.  Correlation versus causation? Pharmacovigilance of the analgesic flupirtine exemplifies the need for refined spontaneous ADR reporting.

Authors:  Nora Anderson; Juergen Borlak
Journal:  PLoS One       Date:  2011-10-11       Impact factor: 3.240
  7 in total
  1 in total

1.  Authors' response to Hermann et al. Minimum quality criteria are needed in the assessment and communication of unexpected drug safety findings of marketed products from RCTs.

Authors:  Koenraad Blot; Martin C Michel
Journal:  Br J Clin Pharmacol       Date:  2012-07       Impact factor: 4.335
  1 in total

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