Good Clinical Practice 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