Changes / developments in the guideline area

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Carcinogenicity

• Storer RD, French JE, Donehower LA, Gulezian D, Mitsumori K, Recio L, Schiestl RH, Sistare FD, Tamaoki N, Usui T, van Steeg H (2003) Transgenic tumor models for carcinogen identification: the heterozygous Trp53-deficient and RasH2 mouse lines. Mutat Res 540: 165-176.
  Above link shows the PubMed abstract
  
  
• EFPIA Comments and Questions regarding the CPMP SWP recommendations on the use of genetically modified animals for carcinogenicity assessment (CPMP/SWP/2592/02)
  EFPIA, April 2003
  size: 27 kB
  
  

QT Prolongation

• The clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs
  ICH, Draft 4, June 2004
  size: 67 kB
  
  
• ICH S7B - The nonclinical evaluation of the potential for delayed ventricular repolarization (QT interval prolongation) by human pharmaceuticals.
  ICH Step 4, May 2005
  size: 12 kB
  
  
• ICH EWG REPORT - S7B: Safety Pharmacology Studies for Assessing the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals
  ICH, February 6, 2003
  size: 41 kB
  
  
• Step 3: Guideline on Safety Pharmacology Studies for Assessing the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals (S7B)
  ICH, February 6, 2003
  size: 51 kB
  
  

Please feel free to contact the Committee for Scientific Standards if you have interesting information or paper to add