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International Conference on Harmonisation - Safety

 Title and Format  Type  Issue Date
S1A The Need for Long-term Rodent Carcinogenicity Studies of Pharmaceuticals  Final 3/1996
S1B Testing for Carcinogenicity of Pharmaceuticals  Final 2/28/1998
S1C(R2) Dose Selection for Carcinogenicity Studies of Pharmaceuticals Final 9/17/2008
S2A Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals Final 4/1996
S2B Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals  Final 11/21/1997
S2(R1) Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use Draft 3/24/2008
S3A Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies  Final 3/1995
S3B Pharmacokinetics: Guidance for Repeated Dose Tissue Distribution Studies  Final 3/1995
S4A Duration of Chronic Toxicity Testing in Animals (Rodent and Nonrodent Toxicity Testing) Final Posted 6/25/99

S5(R2) Detection of Toxicity to Reproduction for Medicinal Products   Toxicity to Male Fertility
Note: In November 2005, the ICH incorporated the S5B addendum with S5A and retitled the combined S5 document. The contents of the two guidances were not revised.

 


Final

Final

 



9/1994

4/1996
S6 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals   Final 11/1997
S7A Safety Pharmacology Studies for Human Pharmaceuticals Final 7/2001
S7B Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals Final 10/19/2005
S8 Immunotoxicity Studies for Human Pharmaceuticals Final 4/12/2006
S9 Nonclinical Evaluation for Anticancer Pharmaceuticals Draft 2/13/2009
    
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