PharmD Info

In this list of ICH Guidelines - Safety covers the guidelines to uncover potential risks like carcinogenicity, genotoxicity, reprotoxicity , QT interval prolongation liability related safety guidelines

List of ICH Guidelines on Safety Topics

S1(R1) EWG Rodent Carcinogenicity Studies for Human Pharmaceuticals

S10 Photosafety Evaluation of Pharmaceuticals

S11 Nonclinical Safety Testing in Support of Development of Paediatric Medicines

S12 EWG Non-clinical Biodistribution Studies for Gene Therapy Products

S1A Need for Carcinogenicity Studies of Pharmaceuticals

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

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 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

S5(R3) Revision of S5 Guideline on Detection of Toxicity to Reproduction for Human Pharmaceuticals

S5(R4) Maintenance EWG Revision of S5 Guideline on Detection of Toxicity to Reproduction for Human Pharmaceuticals

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

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