- ICH Guideline: Duration of Chronic Toxicity Testing in Animals (rodent and non rodent toxicity testing) S4
- ICH Guideline: Note for Guidance on Toxicokinetics: the Assessment of Systemic Exposure in Toxicity Studies
- ICH Guideline: Detection of Toxicity to Reproduction for Medicinal Products & Toxicity to Male Fertility S5(R2)
- ICH Topic S8 Immunotoxicity Studies for Human Pharmaceuticals (May 2006 CHMP/167235/2004)
- ICH Topic S9 Non-clinical Evaluation for Anticancer Pharmaceuticals
Single dose toxicities in rodents, by different administration routes: oral, dermal, intravenous, intramuscular, intra-articular, subcutaneous, intraperitoneal.
Acute oral toxicity by fixed dose method | OECD TG 420 |
Acute oral toxicity by up-and-down procedure | OECD TG 425 |
Acute oral toxicity by toxic class method | OECD TG 423 |
Acute dermal toxicity in rodents | OECD TG 402 |
Repeated dose toxicity in rodents by different administration routes: oral, dermal, intravenous, intramuscular, intra-articular, subcutaneous, intraperitoneal.
- 28-day Oral Toxicity in Rodents (OECD TG 407), including main study, recovery, toxicokinetic
5 rats/sex/group, 4 Groups, 7-Day Dosing
- 28-day Dermal Toxicity in Rodents (OECD TG 410), including main study, recovery, toxicokinetic
5 rats/sex/group, 4 Groups, 7-Day Dosing
- 90-day Oral Toxicity in Rodents (OECD TG 408), including main study, recovery, toxicokinetic
10 rats/sex/group, 4 Groups, 7-Day Dosing
- 90-day Dermal Toxicity in Rodents (OECD TG 411), including main study, recovery, toxicokinetic
10 rats/sex/group, 4 Groups, 7-Day Dosing
- 6-month Oral Toxicity in Rodents (OECD TG 452), including main study, recovery, toxicokinetic
- Reproductive Toxicity in Rodents
- Embryo-Foetal Development in Rats (OECD TG 414)
- Reproduction Toxicity in Rats (OECD TG 443, 415, 416)
Immunotoxicity (unintended immunosuppression or enhancement). The ICH guideline recommends non-clinical testing approaches to identify compounds which have the potential to be immunotoxic, and provides a guidance on a weight-of-evidence decision making approach for immunotoxicity testing:
- Hematology
- Histopathology of lymphoid organs
- NK cell activity
- T-cell Dependent Antibody Response (Plaque assay)
- Mixed lymphocyte reaction
- Antigenicity (induction of humoral response)