International Conference on Harmonisation - Safety
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S1A The Need for Long-term Rodent Carcinogenicity Studies of Pharmaceuticals (PDF - 100KB)
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Final Guidance
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03/01/96
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International Conference on Harmonisation - Safety
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S1B Testing for Carcinogenicity of Pharmaceuticals (PDF - 145KB)
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Final Guidance
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02/28/98
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International Conference on Harmonisation - Safety
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S1C(R2) Dose Selection for Carcinogenicity Studies of Pharmaceuticals (PDF - 185KB)
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Final Guidance
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09/17/08
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International Conference on Harmonisation - Safety
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S2A Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals (PDF - 123KB)
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Final Guidance
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04/01/96
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International Conference on Harmonisation - Safety
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S2B Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals (PDF - 131KB)
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Final Guidance
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11/21/97
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International Conference on Harmonisation - Safety
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S2(R1) Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use (PDF - 427KB)
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Final Guidance
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06/06/12
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International Conference on Harmonisation - Safety
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S3A Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies (PDF - 46KB)
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Final Guidance
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03/01/95
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International Conference on Harmonisation - Safety
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S3B Pharmacokinetics: Guidance for Repeated Dose Tissue Distribution Studies (PDF - 14KB)
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Final Guidance
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03/01/95
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International Conference on Harmonisation - Safety
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S4A Duration of Chronic Toxicity Testing in Animals (Rodent and Nonrodent Toxicity Testing) (PDF - 21KB)
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Final Guidance
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06/25/99
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International Conference on Harmonisation - Safety
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S5A Detection of Toxicity to Reproduction for Medicinal Products S5(R2) Detection of Toxicity to Reproduction for Medicinal Products Toxicity to Male Fertility 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. (PDF - 87KB)
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Final Guidance
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09/01/94
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International Conference on Harmonisation - Safety
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S5B Detection of Toxicity to Reproduction for Medicinal Products: S5(R2) Detection of Toxicity to Reproduction for Medicinal Products Toxicity to Male Fertility 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. (PDF - 98KB)
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Final Guidance
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04/01/96
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International Conference on Harmonisation - Safety
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S6(R1) Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals (July 2011) See Attachment
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Final Guidance
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05/17/12
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International Conference on Harmonisation - Safety
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S7A Safety Pharmacology Studies for Human Pharmaceuticals (PDF - 44KB)
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Final Guidance
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07/01/01
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International Conference on Harmonisation - Safety
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S7B Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals (PDF - 52KB)
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Final Guidance
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10/19/05
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International Conference on Harmonisation - Safety
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S8 Immunotoxicity Studies for Human Pharmaceuticals (PDF - 72KB)
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Final Guidance
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04/12/06
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International Conference on Harmonisation - Safety
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S9 Nonclinical Evaluation for Anticancer Pharmaceuticals (PDF - 169KB)
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Final Guidance
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03/05/10
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