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44th Annual Meeting of the Drug Information Association

22–26 June 2008; Boston, Massachusetts, USA

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Notes

  1. 1.

    1The use of trade names is for product identification purposes only and does not imply endorsement

References

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    International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Revision of the ICH guideline on clinical safety data management data elements for transmission of individual case safety reportsE2B(R3) [online]. Available from URL: International Conference on Harmonisation (ICH) E2B [Accessed 2008 Jul 14]

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    US Food and Drug Administration. Guidance for industry. Drug-induced liver injury: premarketing clinical evaluation [online]. Available from URL: http://www.fda.gov/cder/guidance/7507dft.htm [Accessed 2008 Jul 14]

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    EMEA. ICH Topic E2F: development safety update report. Step 3: note for guidance on development safety update report. EMEA/CHMP/ICH/309348/2008 [online]. Available from URL: http://www.emea.europa.eu/pdfs/human/ich/30934808en.pdf [Accessed 2008 Jul 14]

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Correspondence to Sue Pochon.

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Pochon, S. 44th Annual Meeting of the Drug Information Association. Pharm Med 22, 245–250 (2008). https://doi.org/10.1007/BF03256709

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Keywords

  • Pharmaceutical Medicine
  • Periodic Safety Update Report
  • Development Safety Update Report
  • Idiosyncratic DILI
  • Global Drug Development