Safety Pharmacology Studies and Services

We offer a variety of safety pharmacology services such as the CNS function assessment in rodents, respiratory function assessment, in vitro hERG assay and CVS function assessment (dogs). Respiratory and CVS studies are carried out in our partner facility.

The cardiac potassium channel, hERG is responsible for a rapid delayed rectifier current (IKr), which is primarily responsible for cardiac Action Potential (AP) repolarization. The unique structural properties of hERG make it vulnerable to interaction and inhibition by large numbers of compounds. Inhibition of IKr is the most common cause of cardiac AP prolongation by non-cardiac drugs. Prolonged AP causes prolongation of QT interval and has been associated with fatal ventricular arrhythmia and Torsade de Pointes, which has led to a number of drug withdrawals and failures.

We conduct a CNS function assessment using the modified Irwin’s battery of tests. Typically, various graded concentrations of test articles are formulated in suitable vehicles and administered to rats or mice. The pre and post-dose measurements on the same day are made to evaluate the intra and intergroup comparison of effects.

Our scientists have vast experience in handling various test modules. The studies are conducted in full GLP compliance and data are reviewed by the Quality Assurance team.

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Safety pharmacology studies research and analysis instrument

Safety pharmacology studies research lab

hERG Assay

In vitro assessment of new chemical entities (NCEs) for the effects on hERG potassium channels is an early indicator of possible QT prolonging effect. Patch clamp-electrophysiology is the gold standard for such an assessment. In addition to patch clamp assay, we also offer kit-based hERG assay for the preliminary screening of compounds.

Cardiovascular (CVS) function in dogs

Assessing cardiovascular (CVS) function in dogs is essential for diagnosing and managing heart diseases. This study is conducted to Identify conditions like congestive heart failure, arrhythmias, and congenital heart defects and to assess the impact of heart conditions on the dog's overall health and quality of life.

This study is carried out in jacketed telemetered dogs using a telemeter. ECG, blood pressure and heart rate is measured at specific time points before and after treatment to assess the cardiovascular function.

Assessing CVS function in dogs involves a combination of physical exams, imaging techniques, ECG, blood tests, and advanced diagnostics. These methods help veterinarians diagnose heart conditions, monitor disease progression, and manage treatments effectively, ensuring better health and quality of life for dogs.

Respiratory Function Assessment in Rats

Whole Body Plethysmography (WBP) is used in rats to assess respiratory function assessment, which is a non-invasive method. This technique allows for the measurement of various respiratory parameters without the need for anesthesia or physical restraint, making it ideal for longitudinal studies and minimizing stress on the animals. This study helps to assess the impact of test article on respiratory function and track changes in respiratory parameters over time. Animals are given a single dose of the test article and the following parameters are measured.

Tidal Volume (TV): The amount of air inhaled or exhaled during a normal breath.
Respiratory Rate (RR): The number of breaths taken per minute.
Inspiratory Time (Ti): The duration of the inhalation phase.
Expiratory Time (Te): The duration of the exhalation phase.
Peak Inspiratory Flow (PIF): The maximum flow rate during inhalation.
Peak Expiratory Flow (PEF): The maximum flow rate during exhalation.
Enhanced Pause (Penh): An index used to assess airway resistance and obstruction

Whole Body Plethysmography is a valuable tool for assessing respiratory function in rats. Its non-invasive nature, combined with the ability to measure a wide range of respiratory parameters, makes it ideal for preclinical safety pharmacology studies.

Why Aurigene Pharmaceutical Services?

Quick turnaround time

State-of-the-art facilities

Extensive experience in the hERG assay & GLP FOB studies

Team of expert scientists

Other Services

Carcinogenicity Studies and Services

General Toxicology Services

Genetic Toxicology Studies and Services

In vitro Genotoxicity Testing Services

Reproductive Toxicity Studies

Virtual Tour

Hyderabad R and D Center

Bangalore R and D Center

Toxicology Studies

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We understand that clear communication is essential to successful collaborations, and that's why we have a dedicated team that is always ready to help you. Whether you have questions about our services, want to discuss a potential partnership, or simply want to learn more about our company, we're here to help.

Our team of experts is dedicated to providing personalised solutions tailored to your unique needs. So, please don't hesitate to reach out to us. We look forward to hearing from you and helping you achieve your business goals.

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