Exploratory and General Toxicology

General Toxicology Studies

We offer acute, subacute, chronic toxicity and carcinogenicity studies in compliance with ICH/OECD/NDCT rules or any other regulatory guidelines for IND/NDA/ANDA filings with various regulatory agencies (USFDA/MHRA/European/CDSCO).

A dedicated team of highly skilled scientists of various disciplines carry out the in life and pathology activities. GLP compliant bioanalytical method validations and bioanalysis are performed to support preclinical tox studies. GLP method validations and analysis activities are performed for formulations that are used in Non-Clinical safety studies.

Our vivarium is an AAALAC accredited facility and the clinical pathology analyses and histopathology procedures are performed in state-of-the-art laboratories.

Rodent toxicity studies are conducted in rats and mice, repeat dose toxicity studies are performed for a definitive period of test article administration with or without a recovery period.

Exploratory Toxicology Studies

We offer a wide range of exploratory toxicology studies such as single dose toxicity study, 4-day, 7-day, or 14-day repeat dose toxicity study to determine the MTD and/or NOAEL upon a short period of exposure through the intended clinical route of exposure in human.

Study designs are customized to the client requirements based on the nature of the test compounds and intended product development program.

The end points typically include mortality checks, clinical signs observations, body weight and feed intake measurements, clinical pathology, gross pathology observations, and limited histopathology.

Related Services:

Single Dose Maximum Tolerated Dose

4-Day / 7-Day / 14-Day Repeat Dose DRF Tox Studies

Carcinogenicity Studies

GLP Definitive Tox Studies ( Subacute / Subchronic / Chronic )

Aurigene Pharmaceutical Services is

a leading CDMO/CRO

that provides contract research and manufacturing services

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