Toxicology and Safety Studies

BIOCON is an AAALAC-accredited and USDA-registered laboratory capable of supporting a wide range of in vivo toxicology and safety-assessment studies. We offer safety assessments of investigative new drugs and finished products.

Our studies are GLP compliant, and meet the ICH guidelines on Safety Pharmacology Studies for Human Pharmaceuticals. The studies may be used to support IND submissions.

We design and perform both discovery and preclinical phase safety studies to determine whether biologic materials intended for human use produce either unexpected or unacceptable levels of reactivity in test animals.

Our small-animal models include:

• Mice, rats, guinea pigs, rabbits and ferrets.

Types of studies include:

• Vaccine testing
• General safety (guinea pigs, mice)
• Adventitious virus testing (rabbits, guinea pigs, suckling mice)
• Acute oral toxicity
• Acute dermal toxicity
• Dermal sensitisation (guinea pigs)
• Dermal irritation (rabbits)
• Ocular irritation (rabbits)

Our quality assurance unit works with the GLP Study Director to provide fully-audited final reports to assist investigators in determining the safety and efficacy of their compounds.