European Society of Toxicologic Pathology
Ongoing draft of guidelines
Pharmaceuticals
- Note for guidance on specification limits for residues of metal catalysts
EMEA, January 2004
- Now finalized: Guidance for Industry: Nonclinical Safety Evaluation of Pediatric Drug Products
FDA, February 2006
- Immunotoxicology Evaluation of Investigational New Drugs
FDA, October 2002
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
- Recommendations from the Scientific Advisory Panel Sub-groups on Hepatotoxicity: Hepatotoxicity of Health Products
September 2003
- Hepatocellular hypertrophy - HED guidance document #G0201
October 2002
Chemicals - Neurotoxicity Testing
- Guidance document for neurotoxicity testing
OECD Series on Testing and Assessment No. 20, November 2004
21 CFR Part 11
- Guidance for Industry: Part 11, Electronic Records; Electronic Signatures - Scope and Application
FDA, February 2003
 |
Please feel free to contact the Committee for Scientific Standards if you have interesting information or paper to add |