Tuesday, 19 July 2011

ICH Guidelines for Safety issues in Pharmaceutical Industry

S2(R1): Guidance on Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use
S3A: Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies
S4: Duration of Chronic Toxicity Testing in Animals (Rodent and Non Rodent Toxicity Testing).
S5(R2): Detection of Toxicity to Reproduction for Medicinal Products & Toxicity to Male Fertility.
S6(R1): Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals.
S8: Immunotoxicity Studies for Human Pharmaceuticals.
S9: Nonclinical Evaluation for Anticancer Pharmaceuticals.
S10: Photosafety Evaluation of Pharmaceuticals.

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