Contamination

• EFPIA Workshop: Best Practices to minimize the occurrence of drug in biological samples from control animals
  October 13th 2003
  zipped PowerPoint file, size: 28 kB
  
  
• Position paper/guideline on the toxicokinetic evaluation of control samples in toxicology studies
  EMEA, March 24, 2004
  size: 147 kB
  
  
• Case studies for compound contamination in controls
  May 2004
  zipped Word and Excel files, size: 95 kB
  
  

Impurities

• Position paper on the limits of genotoxic impurities - Draft
  EMEA, December 2002
  size: 51 kB
  
  
• ICH harmonised tripartite guideline - impurities in new drug substances Q3A(R)
  ICH, February 2002
  size: 159 kB
  
  
• ICH harmonised tripartite guideline - impurities in new drug products Q3B(R)
  ICH, February 2003
  size: 149 kB
  
  
• Kroes R, Renwick AG, Cheeseman M, Kleiner J, Mangelsdorf I, Piersma A, Schilter B, Schlatter J, van Schothorst F, Vos JG, Wurtzen G (2004) Structure-based thresholds of toxicological concern (TTC): guidance for application to substances present at low levels in the diet. Food Chem Toxicol 42: 65-83
  Above link shows the PubMed abstract

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