ICH Safety Guidelines

ICH has produced a comprehensive set of safety Guidelines to uncover potential risks like carcinogenicity, genotoxicity and reprotoxicity.  A recent breakthrough has been a non-clinical testing strategy for assessing the QT interval prolongation liability: the single most important cause of drug withdrawals in recent years.

S1A-S1C Carcinogenicity Studies:

S1A Need for Carcinogenicity Studies of Pharmaceuticals

S1B(R1) EWG 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

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:

S11 Nonclinical Safety Testing in Support of Development of Paediatric Medicines

S12 Non-clinical Biodistribution Considerations for Gene Therapy Products:

S12 Non-clinical Biodistribution Considerations for Gene Therapy Products