A dedicated team of highly skilled scientists of various disciplines carry out the toxicology studies. GLP compliant bioanalytical method validations and bioanalysis are performed to support preclinical toxicology 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.
Our state-of-the-art toxicology services facility is GLP certified by National GLP Monitoring Authority (NGCMA) of India. We provide repeat dose 4-day, 7-day or 14-day dose range DRF toxicity studies 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.
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.
GLP Definitive Toxicology Studies
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.
4-Day/7-Day/14-Day Repeat Dose DRF Toxicology Studies
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.
Maximum Tolerated Dose (MTD) Studies
The main objectives of the single dose Maximum Tolerated 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 and 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.
Why Aurigene Pharmaceutical Services?
FDA, OECD, ICH, MHRA regulatory guidelines
Highly experienced and expert toxicology and analytical scientists
AAALAC accredited animal facilities
State-of-the-art facilities equipped with GLP compliant instruments
Wide range of Toxicology services
Other Services
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Bangalore R and D Center
Toxicology Studies
Resources
JULY 02, 2021
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