ICH Safety Guidelines from S1A to S12

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.

ICH Safety Guidelines from S1A to S12

Click on the titles below for complete guidelines

S1A - S1C Carcinogenicity Studies

S2 Genotoxicity Studies

S3A - S3B Toxicokinetics and Pharmacokinetics

S4 Toxicity Testing

S5 Reproductive Toxicology

S6 Biotechnological Products

S7A - S7B Pharmacology Studies

S8 Immunotoxicology Studies

S9 Nonclinical Evaluation for AnticancerPharmaceuticals

S10 Photosafety Evaluation