Literature DB >> 18728269

Opportunities for enhancing the FDA guidance on pharmacovigilance.

Bruce M Psaty1, Jan P Vandenbroucke.   

Abstract

Mesh:

Year:  2008        PMID: 18728269     DOI: 10.1001/jama.300.8.952

Source DB:  PubMed          Journal:  JAMA        ISSN: 0098-7484            Impact factor:   56.272


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  6 in total

1.  Registration of observational studies: is it time?

Authors:  Rebecca J Williams; Tony Tse; William R Harlan; Deborah A Zarin
Journal:  CMAJ       Date:  2010-07-19       Impact factor: 8.262

2.  Randomized controlled trials and assessment of drug safety.

Authors:  David W J Clark; David M Coulter; Frank M C Besag
Journal:  Drug Saf       Date:  2008       Impact factor: 5.606

Review 3.  Postmarketing surveillance for "modified-risk" tobacco products.

Authors:  Richard J O'Connor
Journal:  Nicotine Tob Res       Date:  2011-01-20       Impact factor: 4.244

4.  Causal assessment of pharmaceutical treatments: why standards of evidence should not be the same for benefits and harms?

Authors:  Barbara Osimani; Fiorenzo Mignini
Journal:  Drug Saf       Date:  2015-01       Impact factor: 5.606

Review 5.  Individualized risk for statin-induced myopathy: current knowledge, emerging challenges and potential solutions.

Authors:  QiPing Feng; Russell A Wilke; Tesfaye M Baye
Journal:  Pharmacogenomics       Date:  2012-04       Impact factor: 2.533

6.  Public availability of results of observational studies evaluating an intervention registered at ClinicalTrials.gov.

Authors:  Marie Baudart; Philippe Ravaud; Gabriel Baron; Agnes Dechartres; Romana Haneef; Isabelle Boutron
Journal:  BMC Med       Date:  2016-01-28       Impact factor: 8.775

  6 in total

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