Preclinical Division

The preclinical division of IIRT Labs is driven by a mission to develop reliable and reproducible scientific data while maintaining a healthy balance between animal ethics, welfare and experimentation.

IIRT provides the following core services for domestic and global pharmaceutical, biotech, and medical device companies:
PHARMACOLOGY
DMPK/ADME
SAFETY PHARMACOLOGY
TOXICOLOGY
BIOANALYTICAL

Experiments are designed to generate adequate and robust data in exploratory and regulatory areas using both in vitro and in vivo models. Preclinical evaluation studies are conducted in different modules per the sponsor requirements and in accordance with national and international guidelines (ICH and US FDA, OECD)

NCEs are screened using in vitro systems to facilitate lead optimization and lead identification and in vivo models like mice, rats, guinea pigs, rabbits and beagle dogs through different routes for proof of principle, fast track kinetics and safety assessment, all with GLP compliance.

IIRT TOXICOLOGY – TRACK RECORD

• The Toxicology division was initiated in 1992 at IIRT’s Cherlapally facility.
• This facility was certified for GLP (L1 Grade) by FDA, UP in the year 2015.
• Our initial focus was on agricultural & industrial chemicals. Beginning in 2007, the focus shifted to pharma and biotech industries.
• To meet the current requirements in the area of drug discovery research, activities at the Cherlapally facility were suspended in the year 2005 while a new facility was being designed and built.
• The present facility was started in the year 2008 at S.P. Biotech Park, Genome Valley, Turkapally.

The new 32, 291 sq. ft., state-of-the-art facility was inaugurated in August 2007, delivering a full set of preclinical services.