Toxicology

General Toxicology and Risk Assessment (GLP-Compliant)

Species
Mice, Rats, Guinea Pigs and Rabbits

 

Routes of Administration
Oral, Dermal, Inhalation, Intravenous, Intradermal, Subcutaneous, Intramuscular, Intraperitoneal, Intranasal and Ocular

 

Products Handled
Agrochemicals, Pharmaceuticals, New Chemical Entities (NCE), New Biological Entities (NBE), Industrial Chemicals, Drug Impurities, Veterinary drugs, Nanomaterials, Cosmetics, Feed Additives, Medical Devices, Biosimilars, Biopesticides and other Genetically Modified Products

 

Guidelines Followed
OECD, KCR, ICH, EMEA, EPA, OPPTS, FDA and all other Indian and International regulatory guidelines for conduct of nonclinical environmental and safety studies

 

Single-dose / Special Toxicity Studies
 

Acute Toxicity Studies

Dermal Irritation Study

Eye Irritation Study

Skin Sensitization Study

Inhalation Toxicity Study

Local Lymph Node Assay

In vitro Skin Corrosion/Irritation Studies

Abnormal Toxicity Study

Immunotoxicity Studies

 
Range-finding Toxicity Studies

Exploratory and MTD Studies by Oral and Parenteral Route (Non-GLP)

Flexible Design and Duration

 
Subchronic Toxicity Studies

• 28-day Studies
• 90-day Studies
• Flexible Design and Duration

 
Chronic Toxicity Studies

• Six month or one year studies
• Flexible Design and Duration

 
Carcinogenicity Studies

• Combined Toxicity/Carcinogenicity Studies
• Flexible Design

 

Developmental and Reproductive Toxicology

• Fertility and Early Embryonic Development to Implantation Study in Rats (Segment I)
• Pre-and Post-natal Development Study in Rats (Segment III)
• Embryo-Fetal Development (Teratology) Studies in Rats and Rabbits
• Developmental Screening Studies (Non-GLP)
• One or Two Generation Studies