Description and advantages:
Preclinical Studies for drugs (Efficacy and Safety studies) and Health Safety Assessment for many other products like chemical substances, biocides, medical devices, food ingredients and additives etc. according to requirements of ICH, OECD, US EPA, FDA guidelines in compliance with GLP.
The studies are performed in strictly controlled conditions, with respect to all animal welfare regulations and requirements:
- Acute toxicity studies (Single dose, Maximum tolerated dose (MTD), Extended single dose toxicity)
- Sub-chronic and chronic studies
- Local tolerance studies
- NOAEL (No Observed Adverse Effect)
- Dose selection for subsequent toxicology studies
- Pharmacodynamic studies
- Comprehensive bioequivalence studies working in alliance with preclinical and clinical centers following EMA/FDA/ANVISA guidelines
Capabilities:
- Rodent models: rats and mice
- Different ways of exposure e.g. oral, intravenous, intracutaneous, intradermal, intraperitoneal, intramuscular, topical, inhalation etc. are applied in a variety of species such as mice, rats, rabbits, and guinea pigs.