ICH Guidelines- Safety Guidelines

ICH Safety Guidelines:

Revised ICH Safety Guidelines are listed below:

S1A - S1C Carcinogenicity Studies 

S1 Rodent Carcinogenicity Studies for Human Pharmaceuticals
S1A Need for Carcinogenicity Studies of Pharmaceuticals
S1B Testing for Carcinogenicity of Pharmaceuticals
S1C(R2) Dose Selection for Carcinogenicity Studies of Pharmaceuticals

S2 Genotoxicity Studies 

S2(R1) Guidance on Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use


S3A - S3B Toxicokinetics and Pharmacokinetics 

S3A Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies S3A Q&As Questions and Answers: Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure - Focus on Microsampling
S3B Pharmacokinetics: Guidance for Repeated Dose Tissue Distribution Studies

S4 Toxicity Testing 

S4 Duration of Chronic Toxicity Testing in Animals (Rodent and Non Rodent Toxicity Testing)

S5 Reproductive Toxicology 

S5(R2) Detection of Toxicity to Reproduction for Medicinal Products & Toxicity to Male Fertility S5(R3) Revision of S5 Guideline on Detection of Toxicity to Reproduction for Human Pharmaceuticals

S6 Biotechnological Products 

S6(R1) Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals

S7A - S7B Pharmacology Studies 

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 Immunotoxicology Studies 

S8 Immunotoxicity Studies for Human Pharmaceuticals

S9 Nonclinical Evaluation for Anticancer Pharmaceuticals 

S9 Nonclinical Evaluation for Anticancer Pharmaceuticals
S9 Q&As Questions and Answers: Nonclinical Evaluation for Anticancer Pharmaceuticals

S10 Photosafety Evaluation 

S10 Photosafety Evaluation of Pharmaceuticals

S11 Nonclinical Safety Testing Cross-cutting Topics 

S11 Nonclinical Safety Testing in Support of Development of Paediatric Medicines

Ref:

ICH Safety Guidelines