Pharmaceuticals

• Note for guidance on specification limits for residues of metal catalysts
  EMEA, January 2004
  size: 157 kB
  
  
• Now finalized: Guidance for Industry: Nonclinical Safety Evaluation of Pediatric Drug Products
  FDA, February 2006
  size: 67 kB
  
  
• Immunotoxicology Evaluation of Investigational New Drugs
  FDA, October 2002
  size: 101 kB, FDA Web server
  
  

Hepatotoxicity

• Concept paper on the development of a committee for medicinal products for human use (CHMP) guideline on detection of early signals for hepatotoxicity from non-clinical documentation
  EMEA, June 2004
  size: 120 kB
  
  
• Recommendations from the Scientific Advisory Panel Sub-groups on Hepatotoxicity: Hepatotoxicity of Health Products
  September 2003
  size: 91 kB
  
  
• Hepatocellular hypertrophy - HED guidance document #G0201
  October 2002
  size: 2,085 kB
  
  

Chemicals - Neurotoxicity Testing

• Guidance document for neurotoxicity testing
  OECD Series on Testing and Assessment No. 20, November 2004
  size: 300 kB
  
  

21 CFR Part 11

• Guidance for Industry: Part 11, Electronic Records; Electronic Signatures - Scope and Application
  FDA, February 2003
  size: 39 kB, FDA Web server

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