Our state-of-the-art toxicology services facility is GLP certified by National GLP Monitoring Authority (NGCMA) of India. We perform GLP toxicology studies in rats and mice for supporting IND and ANDA submissions. These studies include subacute (ranging from 14 to 28 days), subchronic (90 days) and chronic (180 days to 2 years) toxicity studies.
Studies are conducted as per the relevant regulatory guidelines (FDA, OECD, ICH, MHRA etc.,) in AAALAC accredited animal facilities.The end points of the GLP repeated dose toxicity studies include mortality checks, observation of clinical signs of toxicity, body weight and food consumption measurements, interim/terminal clinical pathology (hematology, limited or comprehensive clinical pathology, urinalysis etc), gross pathology and limited or comprehensive histopathology.
The in-life phase of these studies are performed by a group of highly experienced toxicologists in AAALAC accredited animal facilities. Our clinical pathology and the histopathology lab is equipped with GLP compliant instruments from internationally reputed suppliers. The computerized systems used in the laboratories are validated and fit for purpose as required by the Principles of GLP.
As required by the study design, satellite toxicokinetic (TK) groups are added to obtain plasma drug exposure at scheduled intervals (e.g., first and last days of dosing). To support formulation analysis and bioanalysis, the Toxicology laboratory coordinates with GLP compliant Analytical and DMPK facilities within the campus.
Based on the sponsor’s requirement, we also conduct multisite studies as required to meet the project objectives.
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