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Expert Opinion on Drug Safety Volume 4, 2005 - Issue 3
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Review

ICH S7B draft guideline on the non-clinical strategy for testing delayed cardiac repolarisation risk of drugs: a critical analysis

Icilio CaveroVia dei Bacchettoni 19B, 55100 LuccaItalyTel/Fax: +39 0583 487520;E-mail: [email protected]
&
William CrumbZenas Technologies LLC 5896 Fleur de Lis Drive, New Orleans, LA 70124USATel: +1 504 988 2426; Fax: +1 504 988 6761;E-mail: [email protected]
Pages 509-530 | Published online: 10 May 2005

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  • ••An extensive, still up-to-date reviewcovering the major issues concerning the non-clinical determination of drug-induced QT liability.
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  • ••A nice, classical review covering the major issues concerning the non-clinical determination of drug-induced QT liability.
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  • •A good experimental study on the value of the canine Purkinje firter test in determining the non-clinical QT liability of drugs.
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  • http://www.emea.eu.int/pdfs/human/swp/ 098696en.pdf COMMITTEE FOR PROPRIETARY MEDICINE PRODUCTS (CPMP) (1997).
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  • ••A document to be read by anyoneInterested in understanding the ICH requirements concerning studies of safety pharmacology on drugs intended for clinical evaluation.

Websites

  • http://www.ich.org/ Ur1GrpServer.jser?@_ID=276 &@_TEMPL ATE=254 ICH Structure (2005).
  • http://www.ich.org/ Ur1GrpServer.jser?@_ID=276 &@_TEMPL ATE=254 The ICH process for harmonisation of guidelines (2005).
  • http://www.ich.org/ Ur1GrpServer.jser?@_ID=276 &@_TEMPL ATE=254 Draft Consensus guideline. The clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs (E14) (2004).
  • ••A document to be read by anyoneinterested in understanding the ICH position on non-clinical determination of drug-induced DT liability.
  • www.fda.gov/ohrms/dockets/ac/03/ transcripts/3956T1.htm (2003).
  • http://www.fda.gov/ohrms/dockets/ac/03/ slides/395651_01_Sanofi-Synthelabo_files/ frame.htm#slide0001.htm (2003).
  • http://www.fda.gov/ohrms/dockets/ac/03/ slides/395651_03_Bayer.ppt (2003) .
  • http://www.fda.gov/ohrms/dockets/ac/03/ transcripts/3956T1.pdf (2003).
  • http://www.fda.gov/ohrms/dockets/ac/03/ slides/401252_05_CVT-Preclinical%20QT.ppt (2003).
  • http://www.fda.gov/ohrms/dockets/ac/03/ transcripts/4012T2.htm (2003).
  • ••A must-read for anyone interestedin understanding the FDA position on non-clinical studies.

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