We conduct tissue distribution studies in rats and mice. These studies are conducted to evaluate the distribution and accumulation of the test compound and/or its metabolites in body tissues. Mostly single dose tissue distribution studies are conducted whereas repeated dose tissue distribution studies may be required for test items having apparently long half-life in the tissues.
The pilot studies are carried out by a team of scientists from DMPK and toxicology teams. In general pilot tissue distribution studies are conducted in non-GLP whereas pivotal studies are conducted in GLP compliance.
The tissue distribution studies are highly customized to meet the client requirements and several modifications to the study protocols are made to ensure flexibility and rigor in study conduct so as to meet the study objectives.
In the experimental setting, animals are exposed to test item formulations. At each specified time point post dosing, blood sample is collected, and various tissues are harvested after a whole-body perfusion.
In addition to the typical tissue distribution study protocols, various clinical pathology and histopathology evaluations are also included to understand the general toxicity nature of the compound from these animal studies. The pathology evaluations are performed in state-of-the-art GLP laboratories. A separate group of scientists in DMPK laboratory analyse the PK data using sophisticated and validated computerized systems.
We have vast experience in conducting tissue distribution studies and could perform the studies with a quick turnaround time and in a cost-effective mode.
Aurigene Pharmaceutical Services is
that provides contract research and manufacturing services
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