Aurigene pharmaceutical services offers single dose Maximum Tolerated Dose (MTD) Studies on rats and mice. The main objectives of the single dose MTD studies is to determine the maximum dose level that is tolerated by the test species and to determine the dose levels for the subsequent repeat dose toxicity studies by the intended clinical / therapeutic exposure.
In the absence of a relevant literature/data for a specific highest test dose, we test up to 2000 mg/kg as a limit dose in line with the recommendations of various international guidelines for conducting acute toxicity studies.
The study is conducted by assigning rats or mice into different treatment groups and exposing them to various graded dose levels to ascertain the toxicity at each dose level an determine the MTD. Essentially, the study end points cover mortality checks (at least twice daily), clinical signs examination for identification of evident toxicity (routine/detailed), body weight and food consumption measurements, gross pathology and as required by the study protocol and a limited histopathology.
We also conduct extended Single dose toxicity studies as per ICH guidelines that include, clinical pathology (hematology, clinical biochemistry & comprehensive histopathology) in addition to the above stated study end points. Formulation analysis for the GLP toxicity studies are performed as required by the client.
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