Good Clinical Practice (GCP) eRegs & Guides- For Your Reference Book 6

ICH - Safety Guidelines S1A – S9 


S1A Guideline on the Need for Carcinogenicity Studies 


S1B Testing for Carcinogenicity of Pharmaceuticals 


S1C(R2) Dose Selection for Carcinogenicity Studies of Pharmaceuticals 


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 

Pharmacokinetics: Guidance for Repeated Dose Tissue Distribution 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 


S7A Safety Pharmacology Studies For Human Pharmaceuticals 


S7B The Non-Clinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) By Human Pharmaceuticals 


S8 Immunotoxicity Studies for Human Pharmaceuticals 


S9 Nonclinical Evaluation for Anticancer Pharmaceuticals