Development References

Scientific Guidelines for Human Medicinal Products

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

M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals (PDF)

M4: Common Technical Document for the Registration of Pharmaceuticals for Human Use – M4S: The CTD – Safety

S1A The Need for Long-term Rodent Carcinogenicity Studies of Pharmaceuticals  (PDF)

S1B Testing for Carcinogenicity of Pharmaceuticals (PDF)

S1C(R2) Dose Selection for Carcinogenicity Studies of Pharmaceuticals (PDF)

Guidance for Industry Carcinogenicity Study Protocol Submissions (PDF)

S2A Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals (PDF)

S2B Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals (PDF)

S3A Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies (PDF)

S3B Pharmacokinetics: Guidance for Repeated Dose Tissue Distribution Studies  (PDF)

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

S5(R2) Detection of Toxicity to Reproduction for Medicinal Products & Toxicity to Male Fertility (PDF)

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

S7A Safety Pharmacology Studies for Human Pharmaceuticals (PDF)

S7B Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals (PDF)

S8 Immunotoxicity Studies for Human Pharmaceuticals (PDF)