In addition to the single dose Maximum Tolerated Dose (MTD) studies, repeat dose 4-day, 7-day or 14-day dose range finding (DRF) toxicity studies are performed in rats and mice. The objectives of these studies are to identify the toxic effects upon specific period of exposure and to determine the MTD and No-Observed-Adverse -Effect-Level (NOAEL). The findings of the DRF studies are used for selection of dosage regimen for the subsequent long term or definitive GLP toxicology studies in rats and mice.
The end points of the DRF toxicity studies include mortality checks, observation of clinical signs of toxicity, body weight and food consumption measurements, terminal clinical pathology (hematology, limited or comprehensive clinical pathology, urinalysis etc), gross pathology and limited or comprehensive histopathology.
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). Based on client requirement, analysis of dose formulation samples will be included to estimate the drug concentration verification and homogeneity analysis. To support formulation analysis and bioanalysis, the Toxicology laboratory coordinates with GLP compliant Analytical and DMPK facilities located within the premises.
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 labs are state-of-the-art facilities equipped with GLP compliant instruments from internationally reputed suppliers. The computerized systems used in these laboratories are validated and fit for purpose as required by the principles of GLP.
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